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 |