Heart-Exercise
by Ge Medical Systems Information Technologies GmbH
510(k) K091594
Heart-Exercise is a Class II device made by Ge Medical Systems Information Technologies GmbH, cleared under FDA 510(k) K091594 on 29 Jul 2009, 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 | NumberK091594 | Date29 Jul 2009 | StatusActive |
Official records
- FDA 510(k) database K091594
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MHX
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
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