Specular Microscope CEM- 530
K-Number: K151706 · 2016-03-17
ApplicantNidek Co., Ltd.
Decision Date2016-03-17
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 2016-03-17 under approval number K151706. 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 2016-03-17. It is manufactured by Nidek Co., Ltd.. The 510(k) number is K151706.
When was Specular Microscope CEM- 530 approved by the FDA?
Specular Microscope CEM- 530 received FDA 510(k) clearance on 2016-03-17, under approval number K151706.
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.
Related Devices (Code: NQE)
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.