FDA 510(k) Application Details - K001308

Device Classification Name Oximeter

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510(K) Number K001308
Device Name Oximeter
Applicant AGILENT TECHNOLOGIES
1201 "B" N. RICE AVE.
OXNARD, CA 93030 US
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Contact GRETEL LUMLEY
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 04/25/2000
Decision Date 05/17/2000
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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