Vyaire 706570
Vyaire 706570 is a Class II device made by Jaeger Medical GmbH, cleared under FDA 510(k) K981366 on 30 Oct 1998 and listed in FDA GUDID since 24 May 2019 (UDI-DI 04250892905679), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04250892905679 | Date24 May 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK981366 | Date30 Oct 1998 | StatusActive |
Official records
- AccessGUDID record 04250892905679
- FDA 510(k) database K981366
Across registries
- FDA 510(k) K981366 decided 30 Oct 1998 Active
- FDA GUDID UDI-DI 04250892905679 listed 24 May 2019 Listed
Timeline
- Cleared FDA 510(k) K981366
- Listed FDA GUDID 04250892905679
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vyaire
- Generic name
- Pulmonary function analysis system, adult
- Model / Ref / Catalog
- 706570
- Primary DI / UDI-DI
- 04250892905679
- 510(k) Number
- FDA product code
- BTY
- GMDN term
- Pulmonary function analysis system, adult
- Device class
- Class II
- Regulation number
- 868.1890
- GUDID distribution status
- In Commercial Distribution
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