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 |