FDA 510(k) Application Details - K973640

Device Classification Name System,Network And Communication,Physiological Monitors

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510(K) Number K973640
Device Name System,Network And Communication,Physiological Monitors
Applicant TRINCORE SYSTEMS, INC.
7409 BUTTERNUT CT.
FORT WORTH, TX 76137-1413 US
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Contact VINCENT OCCHIPINTI
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Regulation Number 870.2300

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Classification Product Code MSX
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Date Received 09/24/1997
Decision Date 03/12/1998
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

FDA Source Information for K973640


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