FDA 510(k) Application Details - K983250

Device Classification Name Computer, Blood-Pressure

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510(K) Number K983250
Device Name Computer, Blood-Pressure
Applicant MAGNETIC RESONANCE EQUIPMENT CORP.
6 WASHINGTON AVE.
BAY SHORE, NY 11706 US
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Contact G.RONALD MORRIS
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Regulation Number 870.1110

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Classification Product Code DSK
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Date Received 09/16/1998
Decision Date 12/12/1999
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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