The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Vitalogik Model 4000/4500.
| Device ID | K073140 |
| 510k Number | K073140 |
| Device Name: | VITALOGIK MODEL 4000/4500 |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-07 |
| Decision Date | 2007-11-21 |
| Summary: | summary |