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FDA 510(k) Application Details - K111897
Device Classification Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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510(K) Number
K111897
Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant
RADIOMETER MEDICAL APS
AAKANDEVEJ 21
COPENHAGEN 2100 DK
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Contact
Martin Gabler
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Regulation Number
862.1120
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Classification Product Code
CHL
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Date Received
07/05/2011
Decision Date
07/19/2011
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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