FDA 510(k) Application Details - K990082

Device Classification Name Oximeter

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510(K) Number K990082
Device Name Oximeter
Applicant EPIC MEDICAL EQUIPMENT SERVICES, INC.
1800 10TH ST., SUITE 300
PLANO, TX 75074 US
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Contact JEFFREY SECUNDA
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 01/11/1999
Decision Date 04/09/1999
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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