Nebulizing Elbow SE Nebulizing Elbow Kit, US
Nebulizing Elbow SE Nebulizing Elbow Kit, US (1120425) is a Class II device made by Respironics Inc., cleared under FDA 510(k) K102240 on 10 Nov 2010 and listed in FDA GUDID since 18 Sep 2016 (UDI-DI 00606959034433), 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 | Number00606959034433 | Date18 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102240 | Date10 Nov 2010 | StatusActive |
Official records
- AccessGUDID record 00606959034433
- FDA 510(k) database K102240
Across registries
- FDA 510(k) K102240 decided 10 Nov 2010 Active
- FDA GUDID UDI-DI 00606959034433 listed 18 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K102240
- Listed FDA GUDID 00606959034433
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nebulizing Elbow
- Generic name
- CPAP/BPAP face mask, single-use
- Model / Ref / Catalog
- SE Nebulizing Elbow Kit, US, 1120425
- Primary DI / UDI-DI
- 00606959034433
- 510(k) Number
- FDA product code
- CAF
- GMDN term
- CPAP/BPAP face mask, single-use
- Device class
- Class II
- Regulation number
- 868.5630
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under CPAP/BPAP face mask, single-use.