FDA 510(k) Application Details - K000712

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

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510(K) Number K000712
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant MEDICAL RESEARCH LABORATORIES, INC.
1000 ASBURY DR. NO.17
BUFFALO GROVE, IL 60089 US
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Contact JOEL ORLINSKY
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 03/02/2000
Decision Date 04/27/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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