Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Nidek Co., Ltd.. It received FDA 510(k) clearance on 2019-04-01 under approval 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. It is manufactured by Nidek Co., Ltd.. The 510(k) number is K190198.

When was Microperimeter MP-3, Microperimeter MP-3 Type S approved by the FDA?

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

What company makes Microperimeter MP-3, Microperimeter MP-3 Type S?

Microperimeter MP-3, Microperimeter MP-3 Type S is manufactured by Nidek Co., Ltd..

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.

Other Devices by Nidek Co., Ltd.

K152729MICROPERIMETER MP-3 K152603Green Laser Photocoagulator GYC-500 K151706Specular Microscope CEM- 530 K170302YELLOW LASER PHOTOCOAGULATOR YLC-500 K163564SLIT LAMP SL-2000 K181345Image Filing Software NAVIS-EX

View all 12 devices →

Related Devices (Code: HKI)

K161727Eyenez Ophthalmic CameraEyenez, LLC K152729MICROPERIMETER MP-3Nidek Co., Ltd. K153239LSFG-NAVISoftcare Co., Ltd. K152869LipiView II Ocular Surface InterferometerTearscience, Inc. K170527Phoenix Clinical ICONPhoenix Technology Group, Inc. Dba Phoenix Clinical K163021HAAG-STREIT FUNDUS MODULE 300Optomed OY

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.

↑