The following data is part of a premarket notification filed by Mennen Medical Ltd. with the FDA for Cerebralogik- Aeeg.
| Device ID | K131789 |
| 510k Number | K131789 |
| Device Name: | CEREBRALOGIK- AEEG |
| Classification | Amplitude-integrated Electroencephalograph |
| Applicant | MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot, IL 76100 |
| Contact | Ifat Shwarts |
| Correspondent | Ifat Shwarts MENNEN MEDICAL LTD. 4 HAYARDEN ST., YAVNE P.O.BOX 102 Rehovot, IL 76100 |
| Product Code | OMA |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-18 |
| Decision Date | 2013-12-27 |
| Summary: | summary |