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510(k) K171028

CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories by GE Healthcare Finland Oy — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2017
Date Received
April 5, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by GE Healthcare Finland Oy

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  • K213336 — Carescape B850, E-musb (April 13, 2022)
  • K213363 — CARESCAPE B450, E-musb (April 13, 2022)
  • K211171 — CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiO (October 21, 2021)
  • K191323 — Carescape B850 (January 29, 2020)
  • K191249 — CARESCAPE B450 (January 24, 2020)
  • K191322 — E-EEGX, N-EEGX (January 22, 2020)
  • K191149 — CARESCAPE B650 (January 21, 2020)
  • K183394 — CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO (May 1, 2019)

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  • K210112 — XChange Device, XChange System (January 30, 2023)