FDA 510(k) Application Details - K142898

Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph

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510(K) Number K142898
Device Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant Radiometer Medical Aps.
Aakandevej 21
Broenshoej 2700 DK
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Contact Lasse Post Moller
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Regulation Number 862.1120

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Classification Product Code CHL
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Date Received 10/06/2014
Decision Date 06/17/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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