FDA 510(k)

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

Numéro K : K242562 · 2025-07-09

DemandeurGe Medical Systems Information Technologies, Inc.

Date de décision2025-07-09

Code produitMHX

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P 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 2025-07-09 under 510(k) number K242562. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K242562.

When did Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P receive FDA 510(k) clearance?

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

Who is the listed applicant for Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P?

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 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.

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Autres dossiers indiquant Ge Medical Systems Information Technologies, Inc. en tant que demandeur

K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P K251670MAC 7 Resting ECG Analysis System K243540Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)K233810Portrait VSM K234130Portrait™ 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 K231870CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System

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Dispositifs connexes (Code : MHX)

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Source officielle

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