FDA 510(k) Application Details - K112173

Device Classification Name Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)

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510(K) Number K112173
Device Name Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Applicant SPACELABS HEALTHCARE
P.O. BOX 3018
NEDERLAND, CO 80466 US
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Contact THOMAS KROENKE
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Regulation Number 868.1700

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Classification Product Code CBR
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Date Received 07/28/2011
Decision Date 10/05/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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