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FDA 510(k) Application Details - K990956
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K990956
Device Name
Computer, Diagnostic, Programmable
Applicant
BIOSENSOR CORP.
11481 RUPP DR.
BURNSVILLE, MN 55337 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
03/22/1999
Decision Date
06/14/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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