GE Client Software v6.9.6 R3
by GE Medical Systems Information Technologies, Inc.
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00840682123532 | Date11 Jul 2017 | StatusListed |
Recalls
-
- Terminated Z-0257-2020
Potential for failure of the patient leakage current test. There is a potential that if another device with electrical connectivity (e.g., ablation device, ECG monitor) fails, then the CLab II Plus Amplifier will not prevent an electric current from completing a circuit, which could cause an electrical shock to a patient.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- GE Client Software
- Generic Name
- Cardiac catheterization monitoring system
- Model / Reference
- v6.9.6 R3
- Primary DI / UDI-DI
- 00840682123532
- 510(k) Number
- FDA Product Code
- DQK
- GMDN Term
- Cardiac catheterization monitoring system
- Device Class
- Class II
- Regulation Number
- 870.1425
- GUDID distribution status
- Not in Commercial Distribution
Other devices from GE Medical Systems Information Technologies, Inc.
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Properties
Other properties (12)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No