Insight Discovery Thermal 900-034
Insight Discovery Thermal 900-034 is a Class II device made by SRS Medical Systems, Inc., cleared under FDA 510(k) K063447 on 16 Aug 2007 and listed in FDA GUDID since 20 Aug 2021 (UDI-DI 00890477000074), 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 | Number00890477000074 | Date20 Aug 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK063447 | Date16 Aug 2007 | StatusActive |
Official records
- AccessGUDID record 00890477000074
- FDA 510(k) database K063447
Across registries
- FDA 510(k) K063447 decided 16 Aug 2007 Active
- FDA GUDID UDI-DI 00890477000074 listed 20 Aug 2021 Listed
Timeline
- Cleared FDA 510(k) K063447
- Listed FDA GUDID 00890477000074
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Insight Discovery Thermal
- Generic name
- Biofeedback system application software
- Model / reference
- 900-034
- Primary DI / UDI-DI
- 00890477000074
- 510(k) Number
- FDA product code
- HCC, IKN
- GMDN term
- Biofeedback system application software
- Device class
- Class II
- Regulation number
- 882.5050, 890.1375
- GUDID distribution status
- In Commercial Distribution
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