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.. Device class: 2.

Clearance details

Applicant
Photonicare, Inc.
Product code
Code QJG
Device class
Class 2
Regulation
21 CFR 892.1560
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Champaign, IL, US
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