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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
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Contact
ELI ORBACH
Other 510(k) Applications for this Contact
Regulation Number
862.2100
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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
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