IVUE, MODEL 100— 510(k) K091404

Substantially Equivalent

Optovue, Inc.

FDA 510(k) clearance K091404 for IVUE, MODEL 100, Substantially Equivalent on 2010-04-22. Applicant: Optovue, Inc..

Clearance details

Applicant: Optovue, Inc.
Product code: Code OBO
Advisory panel: Ophthalmic
Date received: 2009-05-12
Decision date: 2010-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

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