FDA 510(k) Application Details - K954120

Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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510(K) Number K954120
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant MAGNETIC RESONANCE EQUIPMENT CORP.
5 GRANT AVE.
BAY SHORE, NY 11706 US
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Contact G. RONALD MORRIS
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 09/01/1995
Decision Date 04/02/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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