HEARTRAC ECG MONITORING SYSTEM
FDA 510(k) clearance K934913 · decided 1995-06-05
Clearance details
- K-number
- K934913
- Device name
- HEARTRAC ECG MONITORING SYSTEM
- Applicant
- Cardiac Telecom Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-15
- Decision date
- 1995-06-05
- Days to decision
- 598 days
- Clearance type
- Traditional
- Product code
- QYW
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Washington, D.C., DC, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| TEMPUS PRO WITH ENHANCED FEATURES (K133973) | Remote Diagnostic Technologies , Ltd. | 2014-08-14 |
Recalls involving this device
No recalls on record reference this clearance.