FDA 510(k) Application Details - K964815

Device Classification Name	Device, Vibration Threshold Measurement   More FDA Info for this Device
510(K) Number	K964815
Device Name	Device, Vibration Threshold Measurement
Applicant	PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. MIRAMAR, FL 33025 US Other 510(k) Applications for this Company
Contact	PAUL SILVA Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LLN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/29/1996
Decision Date	09/04/1997
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