510(k) K160656
K160656 is an FDA 510(k) premarket notification submitted by Corsens Medical , Ltd. for the device "CorSens". The FDA issued a decision of Substantially Equivalent on November 21, 2016. The device falls under product code DXR (Ballistocardiograph), a Class II device regulated under 21 CFR 870.2320.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 21, 2016
- Date Received
- March 8, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ballistocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2320
- Review Panel
- CV
- Submission Type