FDA 510(k) Application Details - K950387

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

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510(K) Number K950387
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant SPEGAS INDUSTRIES, LTD.
7 HAMARPEH ST., P.O. BOX 45025
91450 JERUSALEM 91450 IS
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Contact SANFORD BROWN
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 02/01/1995
Decision Date 05/03/1995
Decision SE - Substantially Equivalent
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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