FDA 510(k) Application Details - K002223

Device Classification Name Oximeter

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510(K) Number K002223
Device Name Oximeter
Applicant EPIC MEDICAL EQUIPMENT SERVICES, INC.
1800 10TH ST., SUITE 300
PLANO, TX 75074 US
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Contact KRISTA OAKES
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 07/24/2000
Decision Date 08/22/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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