FDA 510(k) Application Details - K993789

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

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510(K) Number K993789
Device Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant GENERAL AIR SERVICE AND SUPPLY
6330 COLORADO BLVD.
COMMERCE CITY, CO 80022 US
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Contact MICHAEL FISHER
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Regulation Number 862.1120

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Classification Product Code CHL
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Date Received 11/09/1999
Decision Date 01/10/2000
Decision SESE - SUBST EQUIV
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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