Passy & Passy, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Passy & Passy, Inc. makes
Passy & Passy, Inc. manufactures tracheostomy speaking valves, including the PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE in 15mm and 22mm sizes and the PASSY-MUIR TRACH VALVE. These devices are designed to enable vocalization for patients with tracheostomies by allowing air to pass through the upper airway during exhalation.
The company’s portfolio is regulated under FDA Class II devices and is listed via 510(k) clearance. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Passy-Muir Trach Valve Ref K851016
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Passy & Passy, Inc. have in the registry?
The registry currently lists 2 devices for Passy & Passy, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Passy & Passy, Inc.'s devices?
Among its 2 most recently registered devices, Passy & Passy, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Passy & Passy, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Passy & Passy, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Passy & Passy, Inc. in the registry?
The most recently registered devices listed for Passy & Passy, Inc. include PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM and PASSY-MUIR TRACH VALVE.