FDA 510(k) Application Details - K984570

Device Classification Name Oximeter

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510(K) Number K984570
Device Name Oximeter
Applicant IN-X CORP.
1610 PIERCE STREET, SUITE 150
LAKEWOOD, CO 80214-1489 US
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Contact CHARLIE HENRY
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 12/23/1998
Decision Date 08/30/2000
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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