FDA 510(k) Application Details - K014294

Device Classification Name Oximeter

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510(K) Number K014294
Device Name Oximeter
Applicant MEDICAL DATA ELECTRONICS
12723 WENTWORTH ST.
ARLETA, CA 91331 US
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Contact GREGORY ALKIRE
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 12/28/2001
Decision Date 01/25/2002
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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