The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Modification To Envoy Patient Monitor.
| Device ID | K011784 |
| 510k Number | K011784 |
| Device Name: | MODIFICATION TO ENVOY PATIENT MONITOR |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MENNEN MEDICAL LTD. KIRYAT WEIZMANN P.O. BOX 102 Rehovot, IL 76100 |
| Contact | Erez Nimrod |
| Correspondent | Erez Nimrod MENNEN MEDICAL LTD. KIRYAT WEIZMANN P.O. BOX 102 Rehovot, IL 76100 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-08 |
| Decision Date | 2001-08-16 |
| Summary: | summary |