FDA 510(k) Application Details - K954168

Device Classification Name Oximeter

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510(K) Number K954168
Device Name Oximeter
Applicant EPIC MEDICAL EQUIPMENT SERVICES, INC.
4643 WESTGROVE
DALLAS, TX 75248 US
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Contact KENNETH F PERDUE
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 09/05/1995
Decision Date 09/12/1996
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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