The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Menntor X7.
| Device ID | K141441 |
| 510k Number | K141441 |
| Device Name: | MENNTOR X7 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MENNEN MEDICAL LTD. 4 HA-YARDEN ST. YAVNE 8122804 P.O. BOX 102 REHOVOT 7610002 Yavne, IL 8122804 |
| Contact | Ifat Shwarts |
| Correspondent | Ifat Shwarts MENNEN MEDICAL LTD. 4 HA-YARDEN ST. YAVNE 8122804 P.O. BOX 102 REHOVOT 7610002 Yavne, IL 8122804 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-02 |
| Decision Date | 2015-01-09 |
| Summary: | summary |