FDA 510(k) Application Details - K953893

Device Classification Name Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

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510(K) Number K953893
Device Name Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
Applicant BIOMEDICAL SENSORS, INC.
SHORT ST.
HIGH WYCOMBE, BUCKS HP11 2QH GB
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Contact KARIMA HEBRI
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Regulation Number 868.1150

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Classification Product Code CCC
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Date Received 08/17/1995
Decision Date 11/04/1997
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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