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FDA 510(k)

Specular Microscope CEM-530

K-Number: K173980 · 2018-03-14

ApplicantNidek Co., Ltd.
Decision Date2018-03-14
Product CodeNQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Specular Microscope CEM-530 is a medical device manufactured by Nidek Co., Ltd.. It received FDA 510(k) clearance on 2018-03-14 under approval number K173980. The device is classified under product code NQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Specular Microscope CEM-530?

Specular Microscope CEM-530 is a medical device that received FDA 510(k) clearance on 2018-03-14. It is manufactured by Nidek Co., Ltd.. The 510(k) number is K173980.

When was Specular Microscope CEM-530 approved by the FDA?

Specular Microscope CEM-530 received FDA 510(k) clearance on 2018-03-14, under approval number K173980.

What company makes Specular Microscope CEM-530?

Specular Microscope CEM-530 is manufactured by Nidek Co., Ltd..

What is the FDA product code for Specular Microscope CEM-530?

The FDA product code for Specular Microscope CEM-530 is NQE.

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

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Related Devices (Code: NQE)

K151706Specular Microscope CEM- 530Nidek Co., Ltd. K171313EM-4000 Specular MicroscopeTomey Corporation K191558Konan Specular Microscope XVIIKonan Medical, Inc.

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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