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510(k) K051804

ABL80 FLEX ANALYZER by Sendx Medical, Inc. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2005
Date Received
July 5, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device Class
Class II
Regulation Number
862.1120
Review Panel
CH
Submission Type

Other clearances by Sendx Medical, Inc.

  • K151639 — ABL80 FLEX and ABL80 FLEX CO-OX (December 7, 2015)
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  • K080370 — ABL 80 CO-OX SYSTEM (July 31, 2008)
  • K994346 — ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM (February 1, 2000)
  • K973742 — SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM (December 3, 1997)

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