FDA 510(k) Application Details - K022677

Device Classification Name Oximeter

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510(K) Number K022677
Device Name Oximeter
Applicant ALARIS MEDICAL SYSTEMS, INC.
10221 WATERIDGE CIR.
SAN DIEGO, CA 92121 US
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Contact RENEE L FLUET
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 08/12/2002
Decision Date 09/11/2002
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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