ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)— 510(k) K120057

Name: FDA 510(k) clearance K120057
Creator: U.S. Food and Drug Administration
Published: 2012-05-11

Substantially Equivalent

Bioptigen, Inc.

FDA 510(k) clearance K120057 for ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS), Substantially Equivalent on 2012-05-11. 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: 2012-01-09
Decision date: 2012-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

Download summary PDF View on FDA.gov ↗

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