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510(k) K223531

CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) by GE Healthcare Finland Oy — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2023
Date Received
November 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by GE Healthcare Finland Oy

  • K213363 — CARESCAPE B450, E-musb (April 13, 2022)
  • K213336 — Carescape B850, E-musb (April 13, 2022)
  • K213181 — CARESCAPE B650, 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)
  • K171028 — CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAi (August 17, 2017)

Other clearances for product code MHX

  • K252726 — IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX10 (February 6, 2026)
  • K252589 — Corvair Monza (January 9, 2026)
  • K250854 — Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); (December 17, 2025)
  • K251702 — IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4 (November 10, 2025)
  • K251146 — IntelliVue Patient monitors MX400, MX450, MX500, MX550 (October 17, 2025)
  • K250453 — IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); (September 2, 2025)
  • K250179 — Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) (July 29, 2025)
  • K242562 — Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (July 9, 2025)
  • K250757 — Radius VSM and Accessories (May 29, 2025)
  • K242962 — Telemetry Monitor 5500 Release 4.0 (867232) (May 5, 2025)