Data / Medical devices / Germany / Respironics Deutschland GmbH & Co.KG
Respironics Deutschland GmbH & Co.KG: FDA-registered device maker in Herrsching Bavaria, Germany, 10 510(k) clearances
Respironics Deutschland GmbH & Co.KG is registered with the FDA (registration 3001400310) in Herrsching Bavaria, Germany. It lists 7 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 10, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001400310
- Address
- Gewerbestr. 17, Herrsching Bavaria, Germany, 82211
- Owner or operator
- Philips Medical Systems International BV (2518422)
- Roles
- Exporter to the US
- First device listed
- December 18, 2007
- Registered through
- 2026
- Brand names listed
- 12/24V Battery Cable w/terminals or adapter, A40 Heated Humidifier, BiPAP A40 Ventilatory Support System, BiPAP autoSV Advanced, DirectView Data Management System, Disposable Adult/Ped Heated Active Circuit, Disposable Adult/Ped Heated Passive Circuit, DreamStation BiPAP AVAPS w/ & w/o Humidifier and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous, Minimal Ventilatory Support, Facility Use Ventilator | MNT | 2 | Exporter to the US | accessdata.fda.gov |
| Continuous, Ventilator, Home Use | NOU | 2 | Exporter to the US | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Exporter to the US | accessdata.fda.gov |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | 2 | Exporter to the US | accessdata.fda.gov |
| Ventilator, Continuous, Facility Use | CBK | 2 | Exporter to the US | accessdata.fda.gov |
| Ventilator, Continuous, Non-Life-Supporting | MNS | 2 | Exporter to the US | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Exporter to the US | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| July 10, 2020 | K200480 | DreamStation 2 System, DreamStation 2 Advanced System | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 18, 2019 | K181166 | Trilogy Evo | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| February 10, 2015 | K140980 | TI NASAL MASK | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 18, 2013 | K131982 | REMSTAR AUTO A-FLEX HT | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 14, 2012 | K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | MNT | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| November 4, 2011 | K111885 | SIMPLYGO PORTABLE OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| June 1, 2011 | K110398 | RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS | BZE | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 30, 2009 | K090539 | BIPAP AUTOSV ADVANCED | MNS | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| May 29, 2009 | K091271 | RESPIRONICS PERFORMAX TOTAL FACE MASK | BZD | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| June 28, 2006 | K061261 | L4 OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Ventilator, Continuous, Facility Use
- All makers of Continuous, Ventilator, Home Use
- All makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
- All makers of Generator, Oxygen, Portable
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Updated July 10, 2020. 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.