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FDA 510(k) Application Details - K970209
Device Classification Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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510(K) Number
K970209
Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant
BCI INTL., INC.
W238 N1650 ROCKWOOD DR.
WAUKESHA, WI 53188 US
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Contact
DONALD J ALEXANDER
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Regulation Number
868.1400
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Classification Product Code
CCK
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Date Received
01/21/1997
Decision Date
04/18/1997
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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