simpleABI ABI-400CL
simpleABI ABI-400CL is a Class II device made by Newman Medical, cleared under FDA 510(k) K110628 on 12 May 2011 and listed in FDA GUDID since 8 Jun 2018 (UDI-DI 00852785008630), 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 | Number00852785008630 | Date8 Jun 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK110628 | Date12 May 2011 | StatusActive |
Official records
- AccessGUDID record 00852785008630
- FDA 510(k) database K110628
Across registries
- FDA 510(k) K110628 decided 12 May 2011 Active
- FDA GUDID UDI-DI 00852785008630 listed 8 Jun 2018 Listed
Timeline
- Cleared FDA 510(k) K110628
- Listed FDA GUDID 00852785008630
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- simpleABI
- Generic name
- Noninvasive vascular ultrasound system
- Model / Ref / Catalog
- ABI-400CL
- Primary DI / UDI-DI
- 00852785008630
- 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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