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FDA 510(k)

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

K-Number: K213234 · 2022-04-12

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2022-04-12
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K213234. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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?

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 is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K213234.

When did 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 receive FDA 510(k) clearance?

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 received FDA 510(k) clearance on 2022-04-12, under 510(k) number K213234.

Who is the listed applicant for 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?

The FDA 510(k) record lists Ge Medical Systems Information Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 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?

The FDA product code for 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 is MHX.

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Other records listing Ge Medical Systems Information Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PK251670MAC 7 Resting ECG Analysis SystemK242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PK243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)K233810Portrait VSMK234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O

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Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo CorporationK252840M12 Telemetry SystemGlobal Instrumentation, LLCK260098ePM 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.K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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