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 |