TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM— 510(k) K031831

Name: FDA 510(k) clearance K031831
Creator: U.S. Food and Drug Administration
Published: 2003-12-19

Substantially Equivalent

Topcon Medical Systems, Inc.

FDA 510(k) clearance K031831 for TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM, Substantially Equivalent on 2003-12-19. Applicant: Topcon Medical Systems, Inc.. Device class: 1.

Clearance details

Applicant: Topcon Medical Systems, Inc.
Product code: Code HKO
Device class: Class 1
Regulation: 21 CFR 886.1760
Advisory panel: Ophthalmic
Date received: 2003-06-13
Decision date: 2003-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paramus, NJ, US

Download summary PDF View on FDA.gov ↗

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