Viasys Respiratory Care, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Viasys Respiratory Care, Inc. makes
Viasys Respiratory Care, Inc. manufactures mechanical ventilators, including the AVEA ventilator and its modified versions, as well as portable spirometers like the Micro Diary Spirometer. These devices are designed for respiratory support and pulmonary function assessment in clinical and home-care settings.
The company’s products fall under FDA Class II devices and are regulated through the 510(k) clearance process in the United States. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with US regulatory requirements.
Catalogue
Modification To Avea Ventilator Ref K073069
Regimes: 510(k) Registry: 510(k)Micro Diary Spirometer Ref K100928
Regimes: 510(k) Registry: 510(k)Avea Ventilator Ref K062093
Regimes: 510(k) Registry: 510(k)
FDA recalls
2006
- 20 Oct 2006 Z-0480-2007 Unclassified (pre-2012) Terminated The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.
Full distribution text
- 20 Oct 2006 Z-0481-2007 Unclassified (pre-2012) Terminated The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.
Full distribution text
- 20 Oct 2006 Z-0480-2007 Unclassified (pre-2012) Terminated The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.
Frequently asked questions
How many devices does Viasys Respiratory Care, Inc. have in the registry?
The registry currently lists 3 devices for Viasys Respiratory Care, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Viasys Respiratory Care, Inc.'s devices?
Among its 3 most recently registered devices, Viasys Respiratory Care, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Viasys Respiratory Care, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Viasys Respiratory Care, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Viasys Respiratory Care, Inc.?
FDA recall records list 2 recalls initiated by Viasys Respiratory Care, Inc., the most recent initiated on 20 Oct 2006. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Viasys Respiratory Care, Inc. in the registry?
The most recently registered devices listed for Viasys Respiratory Care, Inc. include MODIFICATION TO AVEA VENTILATOR, MICRO DIARY SPIROMETER and AVEA VENTILATOR.