CorSens
FDA 510(k) clearance K160656 · decided 2016-11-21
Clearance details
- K-number
- K160656
- Device name
- CorSens
- Applicant
- Corsens Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2016-03-08
- Decision date
- 2016-11-21
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- DXR
- Device class
- 2
- Regulation number
- 870.2320
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Tel Aviv, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.