EnFocus 2300, EnFocus 4400— 510(k) K162783

Substantially Equivalent

Bioptigen, Inc.

FDA 510(k) clearance K162783 for EnFocus 2300, EnFocus 4400, Substantially Equivalent on 2016-12-09. Applicant: Bioptigen, Inc..

Clearance details

Applicant: Bioptigen, Inc.
Product code: Code OBO
Advisory panel: Ophthalmic
Date received: 2016-10-03
Decision date: 2016-12-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Morrisville, NC, US

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