FDA 510(k) Application Details - K983372

Device Classification Name Transducer, Blood-Pressure, Extravascular

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510(K) Number K983372
Device Name Transducer, Blood-Pressure, Extravascular
Applicant SUNSCOPE INTL., INC.
148 SO. 1200 EAST
SALT LAKE CITY, UT 84102 US
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Contact PHIL TRIOLO
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Regulation Number 870.2850

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Classification Product Code DRS
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Date Received 09/24/1998
Decision Date 02/05/1999
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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