FDA 510(k) Application Details - K063872

Device Classification Name	Transducer, Tremor   More FDA Info for this Device
510(K) Number	K063872
Device Name	Transducer, Tremor
Applicant	CLEVELAND MEDICAL DEVICES, INC. 4415 EUCLID AVE CLEVELAND, OH 44103 US Other 510(k) Applications for this Company
Contact	JOSEPH GIUFFRIDA 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	12/29/2006
Decision Date	04/06/2007
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