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

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..

Clearance details

Applicant: Bioptigen, Inc.
Product code: Code HLI
Advisory panel: Ophthalmic
Date received: 2012-01-09
Decision date: 2012-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, US

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