FDA 510(k) Application Details - K971318

Device Classification Name	Transducer, Tremor   More FDA Info for this Device
510(K) Number	K971318
Device Name	Transducer, Tremor
Applicant	AXON INSTRUMENTS, INC. 1101 CHESS DR. FOSTER CITY, CA 94404-1102 US Other 510(k) Applications for this Company
Contact	ANDREW L BLATZ Other 510(k) Applications for this Contact
Regulation Number	882.1950   More FDA Info for this Regulation Number
Classification Product Code	GYD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/09/1997
Decision Date	07/28/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review