FDA 510(k) Application Details - K980299

Device Classification Name Oximeter

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510(K) Number K980299
Device Name Oximeter
Applicant MARQUETTE MEDICAL SYSTEMS, INC.
8200 WEST TOWER AVE.
MILWAUKEE, WI 53223 US
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Contact DAVID WAHLIG
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 01/27/1998
Decision Date 04/24/1998
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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