Model 4000
by Vitalograph Ireland, Ltd. 111 variants
Model 4000 is an expiratory peak flow meter (FDA Class II; FDA product code BZG, Spirometer, Diagnostic) made by Vitalograph Ireland, Ltd., cleared under FDA 510(k) K073155 on 4 Jun 2008 and listed in FDA GUDID since 8 Dec 2016 (UDI-DI 15099169400600), active as of 31 May 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 | Number15099169400600 | Date8 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK073155 | Date4 Jun 2008 | StatusActive |
Official records
- AccessGUDID record 15099169400600
- FDA 510(k) database K073155
Across registries
- FDA 510(k) K073155 decided 4 Jun 2008 Active
- FDA GUDID UDI-DI 15099169400600 listed 8 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K073155
- Listed FDA GUDID 15099169400600
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Expiratory peak flow meter, digital
- Model / reference
- 4000
- Primary DI / UDI-DI
- 15099169400600
- 510(k) Number
- FDA product code
- BZG
- GMDN term
- Expiratory peak flow meter, digital
- Device class
- Class II
- Regulation number
- 868.1840
- GUDID distribution status
- In Commercial Distribution
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