OPHTHALMOSCOPE F-10— 510(k) K072259

Substantially Equivalent

Nidek Co., Ltd.

FDA 510(k) clearance K072259 for OPHTHALMOSCOPE F-10, Substantially Equivalent on 2008-05-06. Applicant: Nidek Co., Ltd.. Device class: 2.

Clearance details

Applicant: Nidek Co., Ltd.
Product code: Code MYC
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2007-08-14
Decision date: 2008-05-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.