The following data is part of a premarket notification filed by Corsens Medical Ltd. with the FDA for Corsens.
| Device ID | K160656 |
| 510k Number | K160656 |
| Device Name: | CorSens |
| Classification | Ballistocardiograph |
| Applicant | CorSens Medical Ltd. 3 Azrieli Center Triangular Tower 33rd Floor 132 Menachem Begin Rd. Tel Aviv, IL 6702301 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy Qsite 31 Haavoda St Binyamina, IL 30500 |
| Product Code | DXR |
| CFR Regulation Number | 870.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-08 |
| Decision Date | 2016-11-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CORSENS 79242819 5742288 Live/Registered |
Creavo Medical Technologies Limited 2018-08-08 |