FDA 510(k) Application Details - K954711

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

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510(K) Number K954711
Device Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant NOVA BIOMEDICAL CORP.
200 PROSPECT ST.
WALTHAM, MA US
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Contact PAUL W MAC DONALD
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Regulation Number 862.1120

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Classification Product Code CHL
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Date Received 09/28/1995
Decision Date 11/30/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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