CardioSoft V6.73
by GE Medical Systems Information Technologies, Inc.
CardioSoft V6.73 is a Class II device made by GE Medical Systems Information Technologies, Inc., cleared under FDA 510(k) K103678 on 16 Feb 2011 and listed in FDA GUDID since 13 May 2016 (UDI-DI 00840682105170), 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 | Number00840682105170 | Date13 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103678 | Date16 Feb 2011 | StatusActive |
Official records
- AccessGUDID record 00840682105170
- FDA 510(k) database K103678
Across registries
- FDA 510(k) K103678 decided 16 Feb 2011 Active
- FDA GUDID UDI-DI 00840682105170 listed 13 May 2016 Listed
Timeline
- Cleared FDA 510(k) K103678
- Listed FDA GUDID 00840682105170
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CardioSoft
- Generic name
- Electrocardiograph, professional, multichannel
- Model / reference
- V6.73
- Primary DI / UDI-DI
- 00840682105170
- 510(k) Number
- FDA product code
- DQK
- GMDN term
- Electrocardiograph, professional, multichannel
- Device class
- Class II
- Regulation number
- 870.1425
- GUDID distribution status
- In Commercial Distribution
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