AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP— 510(k) K851263

Name: FDA 510(k) clearance K851263
Creator: U.S. Food and Drug Administration
Published: 1985-05-01

Substantially Equivalent

American Medical Optics

FDA 510(k) clearance K851263 for AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP, Substantially Equivalent on 1985-05-01. Applicant: American Medical Optics. Device class: 2.

Clearance details

Applicant: American Medical Optics
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 1985-03-28
Decision date: 1985-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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