The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Bis Interface For Vitalogik Patient Monitors.
| Device ID | K083063 |
| 510k Number | K083063 |
| Device Name: | BIS INTERFACE FOR VITALOGIK PATIENT MONITORS |
| Classification | Index-generating Electroencephalograph Software |
| Applicant | MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot, IL 76100 |
| Contact | Ifat Oren |
| Correspondent | Ifat Oren MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot, IL 76100 |
| Product Code | OLW |
| Subsequent Product Code | DSI |
| Subsequent Product Code | OLT |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-14 |
| Decision Date | 2008-12-16 |
| Summary: | summary |