FDA 510(k) Application Details - K840918

Device Classification Name Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

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510(K) Number K840918
Device Name Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Applicant BIOCHEM INTERNATIONAL, INC.


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Regulation Number 868.2500

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Classification Product Code KLK
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Date Received 03/01/1984
Decision Date 04/17/1984
Decision SE - Substantially Equivalent
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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