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510(k) K051092

DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC by Ge Healthcare — Product Code CCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2005
Date Received
April 28, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type

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Other clearances for product code CCL

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  • K213933 — Percent Oxygen Sensors (August 19, 2022)
  • K213948 — OxyMinder (March 17, 2022)
  • K173807 — Accu O2 Oxygen Analyzer (May 2, 2018)
  • K153659 — MaxO2ME (June 10, 2016)
  • K123195 — CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES (February 28, 2013)
  • K122290 — ENVITEC MYSIGN O OXYGEN MEASURING DEVICE (January 23, 2013)
  • K112402 — ULTRAMAXO2 OXYGEN ANALYER (December 14, 2011)