FDA 510(k) Application Details - K110810

Device Classification Name Computer, Oxygen-Uptake

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510(K) Number K110810
Device Name Computer, Oxygen-Uptake
Applicant INVOY TECHNOLOGIES, LLC
1820 E.RAY ROAD
CHANDLER, AZ 85225 US
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Contact LUBNA M AHMAD
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Regulation Number 868.1730

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Classification Product Code BZL
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Date Received 03/23/2011
Decision Date 06/21/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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