FDA 510(k) Application Details - K971549

Device Classification Name	Apparatus, Vestibular Analysis   More FDA Info for this Device
510(K) Number	K971549
Device Name	Apparatus, Vestibular Analysis
Applicant	TARGET HEALTH, INC. 310 MADISON AVE. 22ND FLOOR NEW YORK, NY 10017 US Other 510(k) Applications for this Company
Contact	JULES T MITCHEL Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LXV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/1997
Decision Date	10/05/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review