FDA 510(k) Application Details - K991819

Device Classification Name Oximeter

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510(K) Number K991819
Device Name Oximeter
Applicant MAGNA ADVANCED TECHNOLOGIES, INC.
7200 N.W. SEVENTH ST.
2ND FLOOR
MIAMI, FL 33126 US
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Contact ANNIE VELEZ
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 05/27/1999
Decision Date 08/19/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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