FDA 510(k) Application Details - K823695

Device Classification Name Computer, Oxygen-Uptake

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510(K) Number K823695
Device Name Computer, Oxygen-Uptake
Applicant MEDICOR USA LTD.

, US
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Regulation Number 868.1730

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Classification Product Code BZL
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Date Received 12/08/1982
Decision Date 01/14/1983
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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