CardioXP
CardioXP, an electrocardiograph (FDA Class II; FDA product code DPS, Electrocardiograph) made by Bionet Co., Ltd., was cleared under FDA 510(k) K102767 on 3 Jun 2011 and listed in FDA GUDID on 15 Jul 2021 (UDI-DI 08809276940285); the registry lists it as not in commercial distribution (GUDID) 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 | Number08809276940285 | Date15 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK102767 | Date3 Jun 2011 | StatusActive |
Official records
- AccessGUDID record 08809276940285
- FDA 510(k) database K102767
Across registries
- FDA 510(k) K102767 decided 3 Jun 2011 Active
- FDA GUDID UDI-DI 08809276940285 listed 15 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K102767
- Listed FDA GUDID 08809276940285
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Electrocardiograph, professional, multichannel
- Model / reference
- CardioXP
- Primary DI / UDI-DI
- 08809276940285
- FDA product code
- DPS
- GMDN term
- Electrocardiograph, professional, multichannel
- Device class
- Class II
- Regulation number
- 870.2340
- GUDID distribution status
- Not in Commercial Distribution
- MRI safety
- MR Unsafe
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