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510(k) K080370

ABL 80 CO-OX SYSTEM by Sendx Medical, Inc. — Product Code CHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2008
Date Received
February 12, 2008
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)
  • K151856 — ABL80 FLEX CO-OX with AQURE connectivity (August 6, 2015)
  • K051804 — ABL80 FLEX ANALYZER (November 1, 2005)
  • 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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