Summit Doppler L250AB
Summit Doppler L250AB is a Class II device made by CooperSurgical, Inc., cleared under FDA 510(k) K093393 on 24 Dec 2009 and listed in FDA GUDID since 21 Jul 2016 (UDI-DI 00888937002072), 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 | Number00888937002072 | Date21 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093393 | Date24 Dec 2009 | StatusActive |
Official records
- AccessGUDID record 00888937002072
- FDA 510(k) database K093393
Across registries
- FDA 510(k) K093393 decided 24 Dec 2009 Active
- FDA GUDID UDI-DI 00888937002072 listed 21 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K093393
- Listed FDA GUDID 00888937002072
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Summit Doppler
- Generic name
- Noninvasive vascular ultrasound system
- Model / reference
- L250AB
- Primary DI / UDI-DI
- 00888937002072
- 510(k) Number
- FDA product code
- JAF
- GMDN term
- Noninvasive vascular ultrasound system
- Device class
- Class II
- Regulation number
- 892.1540
- GUDID distribution status
- In Commercial Distribution
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