The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Envoy Patient Monitor.
| Device ID | K024245 |
| 510k Number | K024245 |
| Device Name: | ENVOY PATIENT MONITOR |
| Classification | Reduced- Montage Standard Electroencephalograph |
| Applicant | MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O. BOX 102 Rehovot, IL 76100 |
| Contact | Erez Nimrod |
| Correspondent | Erez Nimrod MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O. BOX 102 Rehovot, IL 76100 |
| Product Code | OMC |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-23 |
| Decision Date | 2004-05-10 |
| Summary: | summary |