The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Ensemble Central Station Monitor.
| Device ID | K970358 |
| 510k Number | K970358 |
| Device Name: | ENSEMBLE CENTRAL STATION MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot, IL 76100 |
| Contact | Alan Schwebel Ph.d. |
| Correspondent | Alan Schwebel Ph.d. MENNEN MEDICAL, INC. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot, IL 76100 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-30 |
| Decision Date | 1998-02-11 |
| Summary: | summary |