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FDA 510(k)

Microperimeter MP-3, Microperimeter MP-3 Type S

K-Number: K190198 · 2019-04-01

ApplicantNidek Co., Ltd.
Decision Date2019-04-01
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Microperimeter MP-3, Microperimeter MP-3 Type S 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 2019-04-01 under 510(k) number K190198. 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 Type S?

Microperimeter MP-3, Microperimeter MP-3 Type S is a medical device that received FDA 510(k) clearance on 2019-04-01. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K190198.

When did Microperimeter MP-3, Microperimeter MP-3 Type S receive FDA 510(k) clearance?

Microperimeter MP-3, Microperimeter MP-3 Type S received FDA 510(k) clearance on 2019-04-01, under 510(k) number K190198.

Who is the listed applicant for Microperimeter MP-3, Microperimeter MP-3 Type S?

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, Microperimeter MP-3 Type S?

The FDA product code for Microperimeter MP-3, Microperimeter MP-3 Type S 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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