FDA 510(k) Application Details - K945264

Device Classification Name	Otoscope   More FDA Info for this Device
510(K) Number	K945264
Device Name	Otoscope
Applicant	OPTUS, INC. 1200 SOUTH PARKER RD. DENVER, CO 80231 US Other 510(k) Applications for this Company
Contact	PETER DUFFY 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	10/28/1994
Decision Date	02/02/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review