Summit Doppler L250AC
Summit Doppler L250AC 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 00888937002089), 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 | Number00888937002089 | Date21 Jul 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK093393 | Date24 Dec 2009 | StatusActive |
Official records
- AccessGUDID record 00888937002089
- FDA 510(k) database K093393
Across registries
- FDA 510(k) K093393 decided 24 Dec 2009 Active
- FDA GUDID UDI-DI 00888937002089 listed 21 Jul 2016 Listed
Timeline
- Cleared FDA 510(k) K093393
- Listed FDA GUDID 00888937002089
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- Withdrawn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
- L250AC
- Primary DI / UDI-DI
- 00888937002089
- 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
Similar devices
Other devices filed under FDA product code JAF (Monitor, Ultrasonic, Nonfetal).
- MEDACORD PVL, PERSONAL VASCULAR LABORATORY by Medasonics, Inc.
- SUPRASTERNAL NOTCH DOP/TRANS. 3MHZ by Philips Medical Systems
- SPEAKER-AMPLIFIER & RECORDER INTERFACE by L&M Ultrascope Life Monitoring Sys.
- MULTILAB 2000 by Unetixs, Inc.
- CAREDOP II by Nicolet Biomedical, Inc.
- ULTRASOUND STETHOSCOPE(R) INTRADOP(R) by Medadonics, Inc.
- IREX 730 MECHANICAL SECTOR SCANNER by Irex Corp.
- Laminar P1 (LDH-HW-001) by Laminar Digital Health, Inc.
- IMEX STETHODOP by Imex Medical Systems, Inc.
- AMBIVASON DR-200 by Kt Medical, Inc.