FDA 510(k) Application Details - K081572

Device Classification Name Oximeter

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510(K) Number K081572
Device Name Oximeter
Applicant HUNTLEIGH HEALTHCARE LTD.
35 PORTMANMOOR RD.
CARDIFF, SOUTH GLAMORGAN CF24 5HN GB
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Contact ROBERT MCCARTHY
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 06/04/2008
Decision Date 10/01/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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