FDA 510(k) Application Details - K043357

Device Classification Name Monitor, Carbon-Dioxide, Cutaneous

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510(K) Number K043357
Device Name Monitor, Carbon-Dioxide, Cutaneous
Applicant LINDE MEDICAL SENSORS AG
AUSTRASSE 25
BASEL 4051 CH
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Contact JEAN-PIERRE PALMA
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Regulation Number 868.2480

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Classification Product Code LKD
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Date Received 12/06/2004
Decision Date 03/04/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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