Panels › Cardiovascular › Product code DRL · Class 2
Tester, Defibrillator
Regulation 870.5325
0510(k)s in 12 months (19 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in DRL
| Company | 510(k)s | Recalls |
|---|---|---|
| Bc Group International, Inc. | 2 | 1 |
| Bio-Tek Instruments, Inc. | 2 | 0 |
| Fluke Biomedical | 2 | 0 |
| Guardian Angel Products, Inc. | 2 | 0 |
| Netech Corp. | 2 | 0 |
| Datrend Systems, Inc. | 1 | 0 |
| Dynatech/Nevada, Inc. | 1 | 0 |
| First Medical Devices Corp. | 1 | 0 |
| Hogan & Hartson | 1 | 0 |
| Instrumentation Laboratory CO | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 22, 2015 | BC Group International Inc DA-2006P - Defibrillator / Pacer Analyzer;
Product Usage:
Intended to measure the output of a defibrillator or transcutaneous pacemaker. Terminated |
DRL | K110192 |
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