Panels › Cardiovascular › Product code DRI · Class 1
Monitor, Line Isolation
Regulation 870.2620
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in DRI
| Company | 510(k)s | Recalls |
|---|---|---|
| Datex Division Instrumentarium Corp. | 2 | 0 |
| Hmba | 1 | 0 |
| MEDLINE INDUSTRIES, LP - Northfield | 0 | 1 |
| Stanco Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 6, 1990 | K902493 | CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR Datex Division Instrumentarium Corp., FI | DRI |
| Jul 6, 1990 | K902492 | CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S Datex Division Instrumentarium Corp., FI | DRI |
| Sep 21, 1982 | K822316 | HEART MONITOR BRACELET ALARM Hmba | DRI |
| Oct 10, 1980 | K802326 | PRESSURE MONITORING LINES Stanco Medical, Inc. | DRI |
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