Amc Cb-A400-1102A
Amc Cb-A400-1102A is a Class II device made by LifeSync Corporation, cleared under FDA 510(k) K992524 on 1 Mar 2000 and listed in FDA GUDID since 25 Jan 2018 (UDI-DI 00849593024372), 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 | Number00849593024372 | Date25 Jan 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK992524 | Date1 Mar 2000 | StatusActive |
Official records
- AccessGUDID record 00849593024372
- FDA 510(k) database K992524
Across registries
- FDA 510(k) K992524 decided 1 Mar 2000 Active
- FDA GUDID UDI-DI 00849593024372 listed 25 Jan 2018 Listed
Timeline
- Cleared FDA 510(k) K992524
- Listed FDA GUDID 00849593024372
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Amc
- Generic name
- Patient monitoring system module, electrocardiographic
- Model / reference
- CB-A400-1102A
- Primary DI / UDI-DI
- 00849593024372
- 510(k) Number
- FDA product code
- DSA
- GMDN term
- Patient monitoring system module, electrocardiographic
- Device class
- Class II
- Regulation number
- 870.2900
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe