FDA 510(k) Application Details - K972992

Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase

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510(K) Number K972992
Device Name Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant CERAMATEC, INC.
2425 SOUTH 900 WEST
SALT LAKE CITY, UT 84119 US
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Contact GORDON ROTH
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Regulation Number 868.1720

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Classification Product Code CCL
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Date Received 08/12/1997
Decision Date 03/30/1998
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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