FDA 510(k) Application Details - K991644

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

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510(K) Number K991644
Device Name Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Applicant LINDE MEDICAL SENSORS AG
AUSTRASSE 25
BASEL 4051 CH
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Contact JEAN-PIERRE PALMA
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Regulation Number 868.2500

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Classification Product Code KLK
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Date Received 05/13/1999
Decision Date 05/21/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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