The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Envoy Patient Monitor.
| Device ID | K030722 |
| 510k Number | K030722 |
| Device Name: | ENVOY PATIENT MONITOR |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | MENNEN MEDICAL, INC. P.O. BOX 102 Rehovot, IL 76100 |
| Contact | Asher Kassel |
| Correspondent | Asher Kassel MENNEN MEDICAL, INC. P.O. BOX 102 Rehovot, IL 76100 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-07 |
| Decision Date | 2004-02-26 |
| Summary: | summary |