FDA 510(k) Application Details - K991086

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

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510(K) Number K991086
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant BCI INTL., INC.
N7 W22025 JOHNSON RD.
WAUKESHA, WI 53186 US
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Contact DONALD ALEXANDER
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 03/31/1999
Decision Date 06/09/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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