FIXATION MONITOR— 510(k) K822601

Name: FDA 510(k) clearance K822601
Creator: U.S. Food and Drug Administration
Published: 1982-09-30

Substantially Equivalent

West Coast Optical Instruments, Inc.

FDA 510(k) clearance K822601 for FIXATION MONITOR, Substantially Equivalent on 1982-09-30. Applicant: West Coast Optical Instruments, Inc.. Device class: 1.

Clearance details

Applicant: West Coast Optical Instruments, Inc.
Product code: Code HPT
Device class: Class 1
Regulation: 21 CFR 886.1605
Advisory panel: Ophthalmic
Date received: 1982-08-27
Decision date: 1982-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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