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510(k) K822820

GAS-FLOW METER GFL 10 by Gambro, Inc. — Product Code DTX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1982
Date Received
September 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas Control Unit, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4300
Review Panel
CV
Submission Type

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  • K896757 — GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS (August 30, 1990)
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  • K892523 — GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY (May 11, 1989)
  • K890112 — ENGSTROM ELIZA + CO2 ANALYZER (March 15, 1989)

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