K970358 is an FDA 510(k) clearance for the ENSEMBLE CENTRAL STATION MONITOR. This device is classified as a Detector And Alarm, Arrhythmia (Class II - Special Controls, product code DSI).
Submitted by Mennen Medical, Inc. (Rehovot, IL). The FDA issued a Cleared decision on February 11, 1998, 377 days after receiving the submission on January 30, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K970358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1997 |
| Decision Date | February 11, 1998 |
| Days to Decision | 377 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSI — Detector And Alarm, Arrhythmia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |