FDA 510(k) Application Details - K041964

Device Classification Name Oximeter

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510(K) Number K041964
Device Name Oximeter
Applicant MEDIAID INC.
2300 MCDERMOTT RD
# 200-207
PLANO, TX 75025 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 07/21/2004
Decision Date 09/14/2004
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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