FDA 510(k) Application Details - K123821

Device Classification Name	Otoscope   More FDA Info for this Device
510(K) Number	K123821
Device Name	Otoscope
Applicant	BLUE FOCUS 965 OAKLAND RD SUITE 2B LAWRENCEVILLE, GA 30044 US Other 510(k) Applications for this Company
Contact	KI CHEOL HAN Other 510(k) Applications for this Contact
Regulation Number	874.4770   More FDA Info for this Regulation Number
Classification Product Code	ERA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2012
Decision Date	05/17/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review