Data / Medical devices / France / Quipment
Quipment: FDA-registered device maker in Nancy Meurthe-et-Moselle, France, 42 510(k) clearances
Quipment is registered with the FDA (registration 3008717264) in Nancy Meurthe-et-Moselle, France. It lists 41 device types. The FDA files 42 510(k) clearances under its listings, the newest dated April 23, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3008717264
- Address
- 269 Rue Julie Victoire Daubie, Nancy Meurthe-et-Moselle, France, 54000
- Owner or operator
- Quipment (10034677)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- December 22, 2010
- Registered through
- 2027
- Brand names listed
- 50mL Conical Centrifuge Tubes Falcon Corning, 352070 (Pack of 25), BBraun, BD PhaSeal Optima Closed System Transfer, Braun Thermoscan PRO 6000 Ear Thermometer, Catheter Endoflip, Cleo 90 Infusion set, Dexcom G7, EASY ON-PC SPIROMETER and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 23, 2024 | K240902 | Dexcom G7 Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| November 20, 2022 | K221282 | Empatica Health Monitoring Platform | DQA | Substantially Equivalent | Empatica S.r.l. | accessdata.fda.gov |
| September 14, 2022 | K222331 | WatchPAT300 (WP300) | MNR | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| August 31, 2022 | K213513 | Vented Vial Adapter 20mm | LHI | Substantially Equivalent | West Pharma. Services IL, Ltd. | accessdata.fda.gov |
| December 11, 2020 | K201046 | Automated ankle brachial pressure index measuring device, MESI mTABLET system | JOM | Substantially Equivalent | Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. | accessdata.fda.gov |
| June 18, 2020 | K200297 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | accessdata.fda.gov |
| March 26, 2020 | K191558 | Konan Specular Microscope XVII | NQE | Substantially Equivalent | Konan Medical, Inc. | accessdata.fda.gov |
| February 15, 2019 | K183072 | EndoFLIP System | FFX | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| November 30, 2018 | K181221 | BD PhaSeal Optima Closed System Transfer Device | ONB | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 26, 2018 | K182041 | Dexcom G6 Glucose Program Continuous Glucose Monitoring System | QDK | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| June 12, 2018 | K172831 | Perfusor® Space Syringe Infusion Pump System | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 19, 2017 | K170182 | CARDIOVIT FT-1 | DPS | Substantially Equivalent | Schiller AG | accessdata.fda.gov |
| March 9, 2017 | K162412 | Hoggan Scientific® microFET2 | LBB | Substantially Equivalent | Hoggan Scientific, LLC | accessdata.fda.gov |
| December 19, 2016 | K162081 | BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| March 1, 2016 | K152748 | Braun Thermoscan PRO 6000 Ear Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) | accessdata.fda.gov |
| February 19, 2016 | K151520 | Oscar 2 | DXN | Substantially Equivalent | Suntech Medical, Inc. | accessdata.fda.gov |
| June 18, 2015 | K142596 | Infusomat Space Volumetric Infusion Pump | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| December 5, 2014 | K140838 | IV ADMINISTRATION SET WITH HAND PUMP | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 17, 2013 | K130906 | ENDOFLIP CATHETER | FFX | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| May 1, 2013 | K121613 | AGILIA INFUSION SYSTEM | FRN | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| September 25, 2012 | K120907 | ZOLL R SERIES | MKJ | Substantially Equivalent | Zoll Medical Corporation, World Wide Headquarters | accessdata.fda.gov |
| December 16, 2011 | K110603 | HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS) | DXN | Substantially Equivalent | I.E.M. GmbH | accessdata.fda.gov |
| July 2, 2010 | K101403 | ELI 250 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| June 18, 2010 | K101115 | ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| November 4, 2009 | K092313 | PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM | MEA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 1, 2009 | K083689 | INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM | FRN | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| June 2, 2009 | K090034 | EASY ON-PC SPIROMETER | BZG | Substantially Equivalent | Ndd Medizitechnik AG | accessdata.fda.gov |
| February 19, 2009 | K090212 | MAC 800 RESTING ECG ANALYSIS SYSTEM | DPS | Substantially Equivalent | Ge Medical Syst. Information Technologies | accessdata.fda.gov |
| November 10, 2008 | K082641 | FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL | DQA | Substantially Equivalent | Contec Medical System Co., Ltd. | accessdata.fda.gov |
| July 13, 2007 | K063641 | PC-60, NON-INVASIVEPULSE OXIMETER | DQA | Substantially Equivalent | Shenzhen Creative Industry Co., Ltd. | accessdata.fda.gov |
| December 1, 2006 | K061712 | SPIROBANK II | BZG | Substantially Equivalent | Mir Medical Intl. Research Srl | accessdata.fda.gov |
| August 17, 2006 | K060559 | ZOLL R SERIES DEFIBRILLATOR | MKJ | Substantially Equivalent | ZOLL Medical Corporation | accessdata.fda.gov |
| March 23, 2006 | K060230 | DOPPLEX CENTRALE | HGM | Substantially Equivalent | Huntleigh Healthcare , Ltd. | accessdata.fda.gov |
| January 24, 2006 | K052773 | B. BRAUN 0.2 MICRON FILTER | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| September 26, 2005 | K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | MLO | Substantially Equivalent | Global Instrumentation, LLC | accessdata.fda.gov |
| October 7, 2004 | K042172 | CLEO 90 INFUSION SET | FPA | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| September 22, 2004 | K041734 | AMBU DISPOSABLE ECG ELECTRODE | DRX | Substantially Equivalent | Ambu, Inc. | accessdata.fda.gov |
| June 27, 2002 | K021373 | H12+HOLTER RECORDER | MWJ | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| April 4, 2002 | K013988 | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R | BSN | Substantially Equivalent | Millipore Corp. | accessdata.fda.gov |
| May 17, 2000 | K000690 | 3M RED DOT RADIOLUCENT MONITORING ELECTRODE WITH CONDUCTIVE ADHESIVE | DRX | Substantially Equivalent | Minnesota Mining and Mfg. Co. | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| May 26, 1994 | K941562 | 1ML LUER-LOK SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
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Updated April 23, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.