FDA 510(k) Application Details - K952325

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

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510(K) Number K952325
Device Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Applicant ICOR AB
ULVSUNDAVAGEN 178 B
BROMMA 161 30 SW
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Contact ANDRAS GEDEON
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Regulation Number 868.1400

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Classification Product Code CCK
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Date Received 05/18/1995
Decision Date 07/31/1995
Decision SE - Substantially Equivalent
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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