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FDA 510(k)

CorSens

K-Number: K160656 · 2016-11-21

ApplicantCorsens Medical , Ltd.
Decision Date2016-11-21
Product CodeDXR
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CorSens is the device name listed in this FDA 510(k) record. The listed applicant is Corsens Medical , Ltd.. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K160656. The device is classified under product code DXR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CorSens?

CorSens is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Corsens Medical , Ltd.. The 510(k) number is K160656.

When did CorSens receive FDA 510(k) clearance?

CorSens received FDA 510(k) clearance on 2016-11-21, under 510(k) number K160656.

Who is the listed applicant for CorSens?

The FDA 510(k) record lists Corsens Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CorSens?

The FDA product code for CorSens is DXR.

Related Devices (Code: DXR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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