CardioTouch3000
CardioTouch3000 is a ST-segment electrocardiographic monitor (FDA Class II; FDA product code DPS, Electrocardiograph) made by Bionet Co., Ltd., cleared under FDA 510(k) K023034 on 14 Nov 2002 and listed in FDA GUDID since 15 Jul 2021 (UDI-DI 08809276943545), 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 | Number08809276943545 | Date15 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023034 | Date14 Nov 2002 | StatusActive |
Official records
- AccessGUDID record 08809276943545
- FDA 510(k) database K023034
Across registries
- FDA 510(k) K023034 decided 14 Nov 2002 Active
- FDA GUDID UDI-DI 08809276943545 listed 15 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K023034
- Listed FDA GUDID 08809276943545
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- ST-segment electrocardiographic monitor
- Model / reference
- CardioTouch3000
- Primary DI / UDI-DI
- 08809276943545
- 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
Similar devices
Other devices filed under FDA product code DPS (Electrocardiograph).
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- GUAVA II by CardioComm Solutions, Inc