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FDA 510(k) Application Details - K974546
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K974546
Device Name
Computer, Diagnostic, Programmable
Applicant
BIOSENSOR CORP.
7001 EAST FISH LAKE RD.
MAPLE GROVE, MN 55311 US
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Contact
STEVE SPRINGROSE
Other 510(k) Applications for this Contact
Regulation Number
870.1425
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Classification Product Code
DQK
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More FDA Info for this Product Code
Date Received
12/04/1997
Decision Date
03/04/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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