FDA 510(k) Application Details - K954731

Device Classification Name Computer, Oxygen-Uptake

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510(K) Number K954731
Device Name Computer, Oxygen-Uptake
Applicant P.K. MORGAN LTD.
4 BLOORS LANE
KENT RAINHAM ME8 7ED GB
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Contact R. H KERNAGHAN
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Regulation Number 868.1730

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Classification Product Code BZL
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Date Received 10/16/1995
Decision Date 01/06/1997
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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