PFT Kit I
PFT Kit I (187126) is a pulmonary function testing kit (FDA Class II; FDA product code CAH, Filter, Bacterial, Breathing-Circuit) made by A-M Systems, LLC, cleared under FDA 510(k) K000654 on 14 Nov 2000 and listed in FDA GUDID since 11 May 2020 (UDI-DI 00817081026672), active as of 22 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 | Number00817081026672 | Date11 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK000654 | Date14 Nov 2000 | StatusActive |
Official records
- AccessGUDID record 00817081026672
- FDA 510(k) database K000654
Across registries
- FDA 510(k) K000654 decided 14 Nov 2000 Active
- FDA GUDID UDI-DI 00817081026672 listed 11 May 2020 Listed
Timeline
- Cleared FDA 510(k) K000654
- Listed FDA GUDID 00817081026672
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Pulmonary function testing kit
- Model / Ref / Catalog
- PFT Kit I, VBMax 36S, w/ White Foam Noseclips - 187126, 187126
- Primary DI / UDI-DI
- 00817081026672
- 510(k) Number
- FDA product code
- CAH
- GMDN term
- Pulmonary function testing kit
- Device class
- Class II
- Regulation number
- 868.5260
- GUDID distribution status
- In Commercial Distribution
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