4503
4503 (Disposable Flow Sensor) is a Class II device made by GaleMed Corporation, cleared under FDA 510(k) K022124 on 3 Apr 2003 and listed in FDA GUDID since 15 Oct 2015 (UDI-DI 44710810085688), active as of 12 Nov 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 | Number44710810085688 | Date15 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK022124 | Date3 Apr 2003 | StatusActive |
Official records
- AccessGUDID record 44710810085688
- FDA 510(k) database K022124
Across registries
- FDA 510(k) K022124 decided 3 Apr 2003 Active
- FDA GUDID UDI-DI 44710810085688 listed 15 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K022124
- Listed FDA GUDID 44710810085688
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Peak flow meter, manual
- Model / Ref / Catalog
- 4503, Disposable Flow Sensor
- Primary DI / UDI-DI
- 44710810085688
- 510(k) Number
- FDA product code
- BZH
- GMDN term
- Peak flow meter, manual
- Device class
- Class II
- Regulation number
- 868.1860
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under Peak flow meter, manual.