AIO HD OTOSCOPE— 510(k) K123821

Substantially Equivalent

Blue Focus

FDA 510(k) clearance K123821 for AIO HD OTOSCOPE, Substantially Equivalent on 2013-05-17. Applicant: Blue Focus.

Clearance details

Applicant: Blue Focus
Product code: Code ERA
Advisory panel: Ear, Nose, Throat
Date received: 2012-12-12
Decision date: 2013-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lawrenceville, GA, US

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