Mac 1600 ECG Analysis System
by GE Medical Systems Information Technologies
510(k) K081437
Mac 1600 ECG Analysis System is a Class II device made by GE Medical Systems Information Technologies, cleared under FDA 510(k) K081437 on 15 Jul 2008, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081437 | Date15 Jul 2008 | StatusActive |
Official records
- FDA 510(k) database K081437
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DPS
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2340
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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