FDA Product Code
FDA Product Code QYW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1025
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K133973 | TEMPUS PRO WITH ENHANCED FEATURES | Remote Diagnostic Technologies , Ltd. | 2014-08-14 | Abbreviated | PDF ↗ |
| K934913 | HEARTRAC ECG MONITORING SYSTEM | Cardiac Telecom Corp. | 1995-06-05 | Traditional | PDF ↗ |
Product code QYW · Class II · Cardiovascular. Data: openFDA.