OtoSight Middle Ear Scope— 510(k) K222655

Substantially Equivalent

Photonicare, Inc.

FDA 510(k) clearance K222655 for OtoSight Middle Ear Scope, Substantially Equivalent on 2022-09-26. Applicant: Photonicare, Inc..

Clearance details

Applicant: Photonicare, Inc.
Product code: Code QJG
Advisory panel: Radiology
Date received: 2022-09-02
Decision date: 2022-09-26
Decision: Substantially Equivalent
Clearance type: Special
Location: Champaign, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.