Pneumotrac 6800
by Vitalograph Ireland, Ltd. 12 variants
Pneumotrac 6800 is a Class II device made by Vitalograph Ireland, Ltd., cleared under FDA 510(k) K142812 on 29 Jun 2015 and listed in FDA GUDID since 19 Aug 2022 (UDI-DI 15099169779577), 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 | Number15099169779577 | Date19 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK142812 | Date29 Jun 2015 | StatusActive |
Official records
- AccessGUDID record 15099169779577
- FDA 510(k) database K142812
Across registries
- FDA 510(k) K142812 decided 29 Jun 2015 Active
- FDA GUDID UDI-DI 15099169779577 listed 19 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K142812
- Listed FDA GUDID 15099169779577
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pneumotrac
- Generic name
- Diagnostic spirometer, professional
- Model / reference
- 6800
- Primary DI / UDI-DI
- 15099169779577
- 510(k) Number
- 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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