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FDA 510(k)

CORIN OPTIMOM MODULAR HEAD

K-Number: K111911 · 2011-08-04

ApplicantCorin USA
Decision Date2011-08-04
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORIN OPTIMOM MODULAR HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2011-08-04 under 510(k) number K111911. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORIN OPTIMOM MODULAR HEAD?

CORIN OPTIMOM MODULAR HEAD is a medical device that received FDA 510(k) clearance on 2011-08-04. The listed applicant is Corin USA. The 510(k) number is K111911.

When did CORIN OPTIMOM MODULAR HEAD receive FDA 510(k) clearance?

CORIN OPTIMOM MODULAR HEAD received FDA 510(k) clearance on 2011-08-04, under 510(k) number K111911.

Who is the listed applicant for CORIN OPTIMOM MODULAR HEAD?

The FDA 510(k) record lists Corin USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORIN OPTIMOM MODULAR HEAD?

The FDA product code for CORIN OPTIMOM MODULAR HEAD is KWL.

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Official Source

View on FDA Database →

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

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