FDA 510(k) Application Details - K962648

Device Classification Name Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)

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510(K) Number K962648
Device Name Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Applicant OHMEDA MEDICAL
1315 W. LOUISVILLE DR.
LOUISVILLE, CO 80027 US
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Contact BILL CURNAN
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Regulation Number 868.1500

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Classification Product Code CBQ
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Date Received 07/08/1996
Decision Date 01/17/1997
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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