SoundBite® Console 9AB-C001091
by Soundbite Medical Solutions Inc 2 variants
SoundBite® Console 9AB-C001091 is a Class II device made by Soundbite Medical Solutions Inc, cleared under FDA 510(k) K210839 on 20 Apr 2021 and listed in FDA GUDID since 30 Jun 2021 (UDI-DI 17540265103028), 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 | Number17540265103028 | Date30 Jun 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210839 | Date20 Apr 2021 | StatusActive |
Official records
- AccessGUDID record 17540265103028
- FDA 510(k) database K210839
Across registries
- FDA 510(k) K210839 decided 20 Apr 2021 Active
- FDA GUDID UDI-DI 17540265103028 listed 30 Jun 2021 Listed
Timeline
- Cleared FDA 510(k) K210839
- Listed FDA GUDID 17540265103028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SoundBite® Console
- Generic name
- Mechanical atherectomy system generator, mechanical output
- Model / reference
- 9AB-C001091
- Primary DI / UDI-DI
- 17540265103028
- 510(k) Number
- FDA product code
- PDU
- GMDN term
- Mechanical atherectomy system generator, mechanical output
- Device class
- Class II
- Regulation number
- 870.1250
- GUDID distribution status
- In Commercial Distribution
- Size
- Weight — 80 KilogramWidth — 13 InchHeight — 42 InchDepth — 22 Inch
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