Hyper-Sal 300F7002
by Pari Respiratory Equipment, Inc.
Hyper-Sal 300F7002 is a Class II device made by Pari Respiratory Equipment, Inc., cleared under FDA 510(k) K070498 on 26 Apr 2007 and listed in FDA GUDID since 17 Nov 2016 (UDI-DI 00744229207603), 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 | Number00744229207603 | Date17 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK070498 | Date26 Apr 2007 | StatusActive |
Official records
- AccessGUDID record 00744229207603
- FDA 510(k) database K070498
Across registries
- FDA 510(k) K070498 decided 26 Apr 2007 Active
- FDA GUDID UDI-DI 00744229207603 listed 17 Nov 2016 Listed
Timeline
- Cleared FDA 510(k) K070498
- Listed FDA GUDID 00744229207603
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hyper-Sal
- Generic name
- Inhalation therapy saline solution, hypertonic
- Model / reference
- 300F7002
- Primary DI / UDI-DI
- 00744229207603
- 510(k) Number
- FDA product code
- CAF
- GMDN term
- Inhalation therapy saline solution, hypertonic
- Device class
- Class II
- Regulation number
- 868.5630
- GUDID distribution status
- In Commercial Distribution
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