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FDA 510(k)

MICROPERIMETER MP-3

K-Number: K152729 · 2016-06-06

ApplicantNidek Co., Ltd.
Decision Date2016-06-06
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MICROPERIMETER MP-3 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Co., Ltd.. It received FDA 510(k) clearance on 2016-06-06 under 510(k) number K152729. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROPERIMETER MP-3?

MICROPERIMETER MP-3 is a medical device that received FDA 510(k) clearance on 2016-06-06. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K152729.

When did MICROPERIMETER MP-3 receive FDA 510(k) clearance?

MICROPERIMETER MP-3 received FDA 510(k) clearance on 2016-06-06, under 510(k) number K152729.

Who is the listed applicant for MICROPERIMETER MP-3?

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

What is the FDA product code for MICROPERIMETER MP-3?

The FDA product code for MICROPERIMETER MP-3 is HKI.

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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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