FDA 510(k) Application Details - K964460

Device Classification Name	Calculator/Data Processing Module, For Clinical Use   More FDA Info for this Device
510(K) Number	K964460
Device Name	Calculator/Data Processing Module, For Clinical Use
Applicant	SHAI SYG MOTION AND INNOVATIONS, LTD. POB 6718 EFRAT 90435 IL Other 510(k) Applications for this Company
Contact	ELI ORBACH Other 510(k) Applications for this Contact
Regulation Number	862.2100   More FDA Info for this Regulation Number
Classification Product Code	JQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/1996
Decision Date	01/24/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review