BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM— 510(k) K063343

Name: FDA 510(k) clearance K063343
Creator: U.S. Food and Drug Administration
Published: 2006-12-13

Substantially Equivalent

Bioptigen, Inc.

FDA 510(k) clearance K063343 for BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM, Substantially Equivalent on 2006-12-13. Applicant: Bioptigen, Inc.. Device class: 2.

Clearance details

Applicant: Bioptigen, Inc.
Product code: Code HLI
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2006-11-06
Decision date: 2006-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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