The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Vitalogik 6000/6500.
| Device ID | K093766 |
| 510k Number | K093766 |
| Device Name: | VITALOGIK 6000/6500 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MENNEN MEDICAL LTD. 4 HA-YARDEN ST. P.O. BOX 102 Yavne, Rehovot, IL 76100 |
| Contact | Ifat Oren Shwarts |
| Correspondent | Ifat Oren Shwarts MENNEN MEDICAL LTD. 4 HA-YARDEN ST. P.O. BOX 102 Yavne, 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 | 2009-12-07 |
| Decision Date | 2010-05-07 |
| Summary: | summary |