EnFocus 2300, EnFocus 4400— 510(k) K150722

Substantially Equivalent

Bioptigen, Inc.

FDA 510(k) clearance K150722 for EnFocus 2300, EnFocus 4400, Substantially Equivalent on 2015-12-02. Applicant: Bioptigen, Inc..

Clearance details

Applicant: Bioptigen, Inc.
Product code: Code HLI
Advisory panel: Ophthalmic
Date received: 2015-03-20
Decision date: 2015-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morrisville, NC, US

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