FDA 510(k) Application Details - K973880

Device Classification Name	Hearing Aid, Air Conduction   More FDA Info for this Device
510(K) Number	K973880
Device Name	Hearing Aid, Air Conduction
Applicant	SONIX TECHNOLOGIES, INC. 5330 SOUTH 900 EAST, SUITE 240 SALT LAKE CITY, UT 84117 US Other 510(k) Applications for this Company
Contact	JEANNETTE SELOOVER JOHNSON Other 510(k) Applications for this Contact
Regulation Number	874.3300   More FDA Info for this Regulation Number
Classification Product Code	ESD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/14/1997
Decision Date	01/12/1998
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