FDA 510(k), K041874, ABL800 FLEX
FDA 510(k), K041874, ABL800 FLEX
Device Name: ABL800 FLEX
Manufacturer: LENE M MARNAES
Device Classification Name: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Regulation Number: CHL
Classification Product Code: KXA
Date Received: 07/12/2004
Decision Date: 10/08/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
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