The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Vitalogik.
| Device ID | K052288 |
| 510k Number | K052288 |
| Device Name: | VITALOGIK |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MENNEN MEDICAL LTD. 4 HAYARDEN ST. Yavne, IL 81228 |
| Contact | Micha Oestereich |
| Correspondent | Micha Oestereich MENNEN MEDICAL LTD. 4 HAYARDEN ST. Yavne, IL 81228 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-23 |
| Decision Date | 2005-12-20 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VITALOGIK 78630844 not registered Dead/Abandoned |
Mennen Medical Corp. 2005-05-16 |