RESPeRATE Deluxe
RESPeRATE Deluxe is a Class II device made by 2BREATHE Technologies Ltd, cleared under FDA 510(k) K020399 on 2 Jul 2002 and listed in FDA GUDID since 19 Nov 2017 (UDI-DI 07290017402017), 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 | Number07290017402017 | Date19 Nov 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK020399 | Date2 Jul 2002 | StatusActive |
Official records
- AccessGUDID record 07290017402017
- FDA 510(k) database K020399
Across registries
- FDA 510(k) K020399 decided 2 Jul 2002 Active
- FDA GUDID UDI-DI 07290017402017 listed 19 Nov 2017 Listed
Timeline
- Cleared FDA 510(k) K020399
- Listed FDA GUDID 07290017402017
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- RESPeRATE
- Generic name
- Biofeedback system
- Model / reference
- Deluxe
- Primary DI / UDI-DI
- 07290017402017
- 510(k) Number
- FDA product code
- HCC
- GMDN term
- Biofeedback system
- Device class
- Class II
- Regulation number
- 882.5050
- GUDID distribution status
- In Commercial Distribution
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