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FDA 510(k)

KERATOR

K-Number: K112787 · 2012-08-08

ApplicantKj Meditech Co., Ltd.
Decision Date2012-08-08
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KERATOR is the device name listed in this FDA 510(k) record. The listed applicant is Kj Meditech Co., Ltd.. It received FDA 510(k) clearance on 2012-08-08 under 510(k) number K112787. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KERATOR?

KERATOR is a medical device that received FDA 510(k) clearance on 2012-08-08. The listed applicant is Kj Meditech Co., Ltd.. The 510(k) number is K112787.

When did KERATOR receive FDA 510(k) clearance?

KERATOR received FDA 510(k) clearance on 2012-08-08, under 510(k) number K112787.

Who is the listed applicant for KERATOR?

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

What is the FDA product code for KERATOR?

The FDA product code for KERATOR is NHA.

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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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