Data / Medical devices / United States / Quipment Inc.
Quipment Inc.: FDA-registered device maker in Kennesaw, GA, United States, 39 510(k) clearances
Quipment Inc. is registered with the FDA (registration 3012302888) in Kennesaw, GA, United States. It lists 41 device types. The FDA files 39 510(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
- 3012302888
- Address
- 1640 Airport Road Suite 105, Kennesaw, GA, United States, 30144
- Owner or operator
- Quipment Inc (10062070)
- Roles
- Repackager or relabeler
- First device listed
- December 16, 2019
- Registered through
- 2027
- Brand names listed
- 3 Liters Calibration Syringe for MicroLab Spirometer, 50mL Conical Centrifuge Tubes Falcon Corning, 352070 (Pack of 25), ABPM Oscar II, BBraun, BP Monitor MicroLife, WatchBP Office 2G, Blood and Infusion Warmer, CABINET, INSTRUMENT, AC-POWERED, OPHTHALMIC, Cardioline H12+ 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 |
| May 15, 2023 | K220526 | HD+12, HD+15 | DRG | Substantially Equivalent | Cardioline S.P.A | accessdata.fda.gov |
| December 7, 2022 | K213919 | 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 |
| July 15, 2021 | K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | QBJ | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| June 30, 2021 | K210753 | KardiaMobile 6L | DXH | Substantially Equivalent | AliveCor, Inc. | 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 |
| June 5, 2019 | K183559 | WatchPAT ONE | MNR | Substantially Equivalent | Itamar Medical , Ltd. | accessdata.fda.gov |
| February 21, 2019 | K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | GJS | Substantially Equivalent | Coagusense, Inc. | accessdata.fda.gov |
| February 15, 2019 | K183072 | EndoFLIP System | FFX | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| January 17, 2019 | K182456 | Study Watch | DXH | Substantially Equivalent | Verily Life Sciences, LLC | 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 |
| 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 |
| July 17, 2013 | K130906 | ENDOFLIP CATHETER | FFX | Substantially Equivalent | Crospon, Ltd. | accessdata.fda.gov |
| July 19, 2012 | K120865 | RSCRIBE ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| July 12, 2012 | K121198 | BW685, BW685S | LGZ | Substantially Equivalent | Biegler 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 |
| February 1, 2010 | K082315 | EC50 MICRO+ SMOKERLYZER | CCJ | Substantially Equivalent | Bedfont Scientific, Ltd. | 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 |
| November 24, 2008 | K082881 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL WATCHBP O3 | DXN | Substantially Equivalent | Microlife Intellectual Property GmbH | 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 |
| March 3, 2006 | K053430 | TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER | HKY | Substantially Equivalent | Medtronic Xomed, 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 |
| December 1, 2003 | K031102 | MICROLAB SPIROMETER | BZG | Substantially Equivalent | Micro Direct, Inc. | accessdata.fda.gov |
| June 11, 1998 | K980987 | BECTON DICKINSON SYRINGE | FMF | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
| April 20, 1998 | K971407 | JTECH COMMANDER AND ALGOMETER | HRW | Substantially Equivalent | J-Tech Medical, Inc. | 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.