FDA 510(k) Application Details - K010270

Device Classification Name	Transducer, Tremor   More FDA Info for this Device
510(K) Number	K010270
Device Name	Transducer, Tremor
Applicant	FLEXABLE SYSTEMS, INC. 16410 E. TOMSTONE AVE. FOUNTAIN HILLS, AZ 85268-6545 US Other 510(k) Applications for this Company
Contact	ROBERT M TRIPP 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	01/29/2001
Decision Date	07/25/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review