MONOCULAR DIRECT OPHTHALMOSCOPE— 510(k) K844971

Substantially Equivalent

Nidek, Inc.

FDA 510(k) clearance K844971 for MONOCULAR DIRECT OPHTHALMOSCOPE, Substantially Equivalent on 1985-02-15. Applicant: Nidek, Inc.. Device class: 2.

Clearance details

Applicant: Nidek, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1984-12-24
Decision date: 1985-02-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, CA, 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.