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510(k) K191149

CARESCAPE B650 by GE Healthcare Finland Oy — Product Code MHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2020
Date Received
April 30, 2019
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

  • K223531 — CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 (April 6, 2023)
  • K213181 — CARESCAPE B650, E-musb (April 13, 2022)
  • 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)
  • 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)

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  • K250757 — Radius VSM and Accessories (May 29, 2025)
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