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 | K000563 |
| 510k Number | K000563 |
| Device Name: | MODIFICATION TO ENVOY PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | MENNEN MEDICAL LTD. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot, IL 76100 |
| Contact | Kenneth Raichman |
| Correspondent | Kenneth Raichman MENNEN MEDICAL LTD. KIRYAT WEIZMANN SCIENCE PARK P.O. BOX 102 Rehovot, IL 76100 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-22 |
| Decision Date | 2000-05-17 |