FDA 510(k) Application Details - K070128

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

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510(K) Number K070128
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant Westmed, Inc.
5580 S. NOGALES HIGHWAY
TUCSON, AZ 85706 US
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Contact DALE BICKLEY
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 01/16/2007
Decision Date 02/15/2007
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 Y
Expedited Review



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