FDA 510(k) Application Details - K951038

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

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510(K) Number K951038
Device Name Analyzer, Gas, Oxygen, Gaseous-Phase
Applicant OXYCHECK, INC.
454 WASHINGTON ST.
NORWELL, MA 02061 US
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Contact GERRY BERKELAAR
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Regulation Number 868.1720

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Classification Product Code CCL
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Date Received 03/07/1995
Decision Date 01/11/1996
Decision SESE - SUBST EQUIV
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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