CorSens— 510(k) K160656

Substantially Equivalent

Corsens Medical , Ltd.

FDA 510(k) clearance K160656 for CorSens, Substantially Equivalent on 2016-11-21. Applicant: Corsens Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Corsens Medical , Ltd.
Product code: Code DXR
Device class: Class 2
Regulation: 21 CFR 870.2320
Advisory panel: Cardiovascular
Date received: 2016-03-08
Decision date: 2016-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.