FDA 510(k) Application Details - K160582

Device Classification Name Oximeter

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510(K) Number K160582
Device Name Oximeter
Applicant Athena GTX
5900 NW 86th Street, Suite 300
Johnston, IA 50131 US
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Contact Sean Mahoney
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 03/01/2016
Decision Date 09/02/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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