Data / Medical devices / United States / Jaeger Medical America Inc.
Jaeger Medical America Inc.: FDA-registered device maker in Moreno Valley, CA, United States, 26 510(k) clearances
Jaeger Medical America Inc. is registered with the FDA (registration 3033959233) in Moreno Valley, CA, United States. It lists 20 device types. The FDA files 26 510(k) clearances under its listings, the newest dated August 23, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033959233
- Address
- 14050 Rebecca St Bldg 4, Moreno Valley, CA, United States, 92553
- Owner or operator
- Jaeger Medical GmbH (10092652)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- February 3, 2025
- Registered through
- 2026
- Brand names listed
- 706960 Pressure Regulator, APS Pro, CO Test, CO2 Test, Calibration Syringe V-720254-13, Disposable Mouthpiece, Flex V-892893, Disposable Mouthpiece, Flex V-892894, Disposable Mouthpiece, Flex V-892897 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 |
|---|---|---|---|---|---|---|
| August 23, 2019 | K183567 | Vyntus/SentrySuite Product Line | BZC | Substantially Equivalent | Vyaire Medical | accessdata.fda.gov |
| August 16, 2019 | K190853 | Vyntus BODY | BZC | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| November 30, 2018 | K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART | BZC | Substantially Equivalent | Vyaire Medical, Inc. | accessdata.fda.gov |
| September 16, 2016 | K153654 | Sentry WEB SmartInterp | DQK | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| August 14, 2015 | K150810 | Vyntus / SentrySuite Product Line | BZC | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| March 20, 2015 | K142959 | Vyntus Walk | DQA | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| August 22, 2014 | K133925 | VYNTUS/ SENTRYSUITE PRODUCT LINE | BZC | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| November 19, 2012 | K122699 | SENTRYSUITE PRODUCT LINE | BTY | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| May 10, 2012 | K113813 | SENTRYSUITE PRODUCT LINE | BTY | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| October 17, 2011 | K111408 | MICROGARD II | CAH | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| August 12, 2011 | K111053 | SENTRYSUITE PRODUCT LINE | BTY | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| February 10, 2011 | K101873 | MASTERSCREEN IOS | BZG | Substantially Equivalent | Carefusion Germany 234 GmbH | accessdata.fda.gov |
| April 22, 2008 | K072061 | MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY | JEH | Substantially Equivalent | Viasys Healthcare GmbH | accessdata.fda.gov |
| October 10, 2007 | K072323 | MASTERSCREEN & OXYCON CPX | BZC | Substantially Equivalent | Viasys Healthcare GmbH | accessdata.fda.gov |
| August 14, 2007 | K071753 | MASTERSCREEN PNEUMO & MASTERSCOPE | BTY | Substantially Equivalent | Viasys Healthcare GmbH | accessdata.fda.gov |
| April 7, 2004 | K040698 | MASTERSCREEN CPX AND OXYCON CPX | BZC | Substantially Equivalent | Viasys Healthcare GmbH | accessdata.fda.gov |
| July 12, 2000 | K001502 | AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO | BZC | Substantially Equivalent | Erich Jaeger GmbH | accessdata.fda.gov |
| October 30, 1998 | K981366 | STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES | BTY | Substantially Equivalent | Sensor Medics Corp. | accessdata.fda.gov |
| February 3, 1995 | K936108 | MASTERSCREEN BODY | JEH | Substantially Equivalent | Erich Jaeger GmbH & Co. KG | accessdata.fda.gov |
| November 22, 1994 | K942211 | VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS | BTY | Substantially Equivalent | Sensor Medics Corp. | accessdata.fda.gov |
| March 7, 1994 | K933839 | MASTER SCREEN PNUEMO | BTY | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| September 3, 1985 | K853360 | N20 TEST | CBR | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| December 4, 1984 | K843843 | HE TEST | BSE | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| October 12, 1984 | K843847 | O2 TEST | CCL | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| October 12, 1984 | K843845 | CO TEST | CCJ | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
| October 12, 1984 | K843844 | CO2 TEST | CCK | Substantially Equivalent | Erich Jaeger, Inc. | accessdata.fda.gov |
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Updated August 23, 2019. 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.