Spirotrac 7000
by Vitalograph Ireland, Ltd. 5 variants
Spirotrac 7000 is a Class II device made by Vitalograph Ireland, Ltd., cleared under FDA 510(k) K141546 on 3 Sep 2014 and listed in FDA GUDID since 30 Apr 2021 (UDI-DI 65099169688003), 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 | Number65099169688003 | Date30 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK141546 | Date3 Sep 2014 | StatusActive |
Official records
- AccessGUDID record 65099169688003
- FDA 510(k) database K141546
Across registries
- FDA 510(k) K141546 decided 3 Sep 2014 Active
- FDA GUDID UDI-DI 65099169688003 listed 30 Apr 2021 Listed
Timeline
- Cleared FDA 510(k) K141546
- Listed FDA GUDID 65099169688003
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Spirotrac
- Generic name
- Diagnostic spirometer, professional
- Model / reference
- 7000
- Primary DI / UDI-DI
- 65099169688003
- FDA product code
- BZG
- GMDN term
- Diagnostic spirometer, professional
- Device class
- Class II
- Regulation number
- 868.1840
- GUDID distribution status
- In Commercial Distribution
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