Heartrak Af
510(k) K071130
Heartrak Af is a Class II device made by Universal Medical, Inc., cleared under FDA 510(k) K071130 on 14 May 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 | NumberK071130 | Date14 May 2008 | StatusActive |
Official records
- FDA 510(k) database K071130
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DXH
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2920
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone).
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- MEMORYTRACE MODEL 4224 AMBULATORY ECG MONITOR by Hi-Tronics Designs, Inc.
- R-1000 ECG RECEIVER by Brentwood Instruments, Inc.
- CARD GUARD MODEL CG-8000 by Card Guard Scientific Survival, Ltd.
- MODEL TT-185 TELEMETRY TRANSMITTER by Eaton Medical Group
- Halo AF Detection System by Livmor
- Study Watch by Verily Life Sciences, LLC
- INSTANT MEMORY 2000 by Telescan Medical Systems
- CG-1000 PERSONAL ECG TRANSMITTER by Card Guard Scientific Survival, Ltd.
- AFIBALERT ATRIAL FIBRILLATION DETECTOR by Lechnologies Research, Inc.