In-Check 3109300
by Clement Clarke International Limited
In-Check 3109300 is a Class II device made by Clement Clarke International Limited, cleared under FDA 510(k) K980960 on 10 Jun 1998 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 05023323000897), 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 | Number05023323000897 | Date7 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK980960 | Date10 Jun 1998 | StatusActive |
Official records
- AccessGUDID record 05023323000897
- FDA 510(k) database K980960
Across registries
- FDA 510(k) K980960 decided 10 Jun 1998 Active
- FDA GUDID UDI-DI 05023323000897 listed 7 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K980960
- Listed FDA GUDID 05023323000897
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- In-Check
- Generic name
- Incentive spirometer
- Model / Ref / Catalog
- 3109300
- Primary DI / UDI-DI
- 05023323000897
- 510(k) Number
- FDA product code
- BZH
- GMDN term
- Incentive spirometer
- Device class
- Class II
- Regulation number
- 868.1860
- GUDID distribution status
- In Commercial Distribution
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