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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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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