CardioCare2000
CardioCare2000 is a ST-segment electrocardiographic monitor (FDA Class II; FDA product code DPS, Electrocardiograph) made by Bionet Co., Ltd., cleared under FDA 510(k) K011328 on 21 Nov 2001 and listed in FDA GUDID since 15 Jul 2021 (UDI-DI 08809276943538), active as of 12 Nov 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 | Number08809276943538 | Date15 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK011328 | Date21 Nov 2001 | StatusActive |
Official records
- AccessGUDID record 08809276943538
- FDA 510(k) database K011328
Across registries
- FDA 510(k) K011328 decided 21 Nov 2001 Active
- FDA GUDID UDI-DI 08809276943538 listed 15 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K011328
- Listed FDA GUDID 08809276943538
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- ST-segment electrocardiographic monitor
- Model / reference
- CardioCare2000
- Primary DI / UDI-DI
- 08809276943538
- 510(k) Number
- FDA product code
- DPS
- GMDN term
- ST-segment electrocardiographic monitor
- Device class
- Class II
- Regulation number
- 870.2340
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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