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FDA 510(k)

OPHTHALMOSCOPE F-10

K-Number: K072259 · 2008-05-06

ApplicantNidek Co., Ltd.
Decision Date2008-05-06
Product CodeMYC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPHTHALMOSCOPE F-10 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 2008-05-06 under 510(k) number K072259. The device is classified under product code MYC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPHTHALMOSCOPE F-10?

OPHTHALMOSCOPE F-10 is a medical device that received FDA 510(k) clearance on 2008-05-06. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K072259.

When did OPHTHALMOSCOPE F-10 receive FDA 510(k) clearance?

OPHTHALMOSCOPE F-10 received FDA 510(k) clearance on 2008-05-06, under 510(k) number K072259.

Who is the listed applicant for OPHTHALMOSCOPE F-10?

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 OPHTHALMOSCOPE F-10?

The FDA product code for OPHTHALMOSCOPE F-10 is MYC.

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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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