Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P

K-Number: K242562 · 2025-07-09

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2025-07-09
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2025-07-09 under approval number K242562. 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 Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P?

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is a medical device that received FDA 510(k) clearance on 2025-07-09. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K242562.

When was Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P approved by the FDA?

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P received FDA 510(k) clearance on 2025-07-09, under approval number K242562.

What company makes Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P?

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is manufactured by Ge Medical Systems Information Technologies, Inc..

What is the FDA product code for Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P?

The FDA product code for Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P is MHX.

Other Devices by Ge Medical Systems Information Technologies, Inc.

K152993MUSE Cardiology Information System K170155EK12 Algorithm K173830MAC VU360 Resting ECG Analysis System K202189Graffiti K201941Monitor B125, Monitor B105 K203786MAC 7 - Resting ECG Analysis System

View all 20 devices →

Related Devices (Code: MHX)

K160981Patient MonitorEdan Instruments, Inc. K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800Philips Medizin Systeme Boeblingen GmbH K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems

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.

↑