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FDA 510(k) Application Details - K862344
Device Classification Name
Transducer, Blood-Pressure, Extravascular
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510(K) Number
K862344
Device Name
Transducer, Blood-Pressure, Extravascular
Applicant
BIO-TEK INSTRUMENTS, INC.
HIHGLAND PARK
BOX 998
WINOOSKI, VT US
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Contact
KLYZEIKO
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Regulation Number
870.2850
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Classification Product Code
DRS
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More FDA Info for this Product Code
Date Received
06/20/1986
Decision Date
08/06/1986
Decision
SE - Substantially Equivalent
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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