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FDA 510(k) Application Details - K203790
Device Classification Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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510(K) Number
K203790
Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant
Instrumentation Laboratory Co.
180 Hartwell Road
Bedford, MA 01730 US
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Contact
Gabriella Erdosy
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Regulation Number
862.1120
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Classification Product Code
CHL
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More FDA Info for this Product Code
Date Received
12/28/2020
Decision Date
08/20/2021
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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