The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Ems-xl Cardiac Electrophysiology System.
| Device ID | K071348 |
| 510k Number | K071348 |
| Device Name: | EMS-XL CARDIAC ELECTROPHYSIOLOGY SYSTEM |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MENNEN MEDICAL LTD. 4 HA-YARDEN ST. P.O. BOX 102 Yavne, Rehovot, IL 76100 |
| Contact | Micha Oestereich |
| Correspondent | Micha Oestereich MENNEN MEDICAL LTD. 4 HA-YARDEN ST. P.O. BOX 102 Yavne, Rehovot, IL 76100 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-14 |
| Decision Date | 2007-09-07 |
| Summary: | summary |