IVUE 500— 510(k) K133892

Substantially Equivalent

Optovue, Inc.

FDA 510(k) clearance K133892 for IVUE 500, Substantially Equivalent on 2014-03-19. Applicant: Optovue, Inc..

Clearance details

Applicant: Optovue, Inc.
Product code: Code HLI
Advisory panel: Ophthalmic
Date received: 2013-12-20
Decision date: 2014-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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