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510(k) K213234

Device
CARESCAPE ONE And CARESCAPE DOCK F0, Model Numbers MBZ323 And MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 And MKS201
Applicant
GE Medical Systems Information Technologies, Inc.
510(k) number
K213234
Product code
MHX  
Decision
Substantially Equivalent (SESE)
Decision date
2022-04-12
Date received
2021-09-30
Regulation
870.1025
Classification name
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joel Kent
Address
9900 Innovation Dr. Wauwatosa WI US 53226 53226

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MHX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254209Radius VSM and AccessoriesMasimo Corporation2026-06-04
K252840M12 Telemetry SystemGlobal Instrumentation, LLC2026-05-29
K260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.2026-05-20
K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.2026-04-24
K253170uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsShenzhen Mindray Bio-Medical Electronics Co., Ltd.2026-04-16
K252250Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427)Shanghai Draeger Medical Instrument Co., Ltd.2026-04-10
K252726IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036)Philips Medizin Systeme Boeblingen GmbH2026-02-06
K252589Corvair MonzaAliveCor, Inc.2026-01-09
K250854Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)Shenzhen Comen Medical Instruments Co.,Ltd2025-12-17
K251702IntelliVue Patient Monitor MX750; IntelliVue Patient Monitor MX850; IntelliVue 4-Slot Module Rack FMX-4 (866471 866470 866468 )Philips Medizin Systeme Böblingen GmbH2025-11-10
K251146IntelliVue Patient monitors MX400, MX450, MX500, MX550Philips Medizin Systeme Boeblingen GmbH2025-10-17
K250453IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)Philips Medizin Systeme Böblingen GmbH2025-09-02
K250179Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)Edan Instruments, Inc.2025-07-29
K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.2025-07-09
K250757Radius VSM and AccessoriesMasimo Corporation2025-05-29

Legacy Summary#

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FDA Review#

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