FDA 510(k) Application Details - K222655

Device Classification Name	More FDA Info for this Device
510(K) Number	K222655
Device Name	OtoSight Middle Ear Scope
Applicant	PhotoniCare, Inc 1902 Fox Drive, Suite F Champaign, IL 61820 US Other 510(k) Applications for this Company
Contact	Ryan Shelton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2022
Decision Date	09/26/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review