FDA 510(k)

MAC 7 Resting ECG Analysis System

K-Nummer: K251670 · 2026-01-26

AntragstellerGe Medical Systems Information Technologies, Inc.

Entscheidungsdatum2026-01-26

ProduktcodeDPS

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

MAC 7 Resting ECG Analysis System 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 2026-01-26 under 510(k) number K251670. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the MAC 7 Resting ECG Analysis System?

MAC 7 Resting ECG Analysis System is a medical device that received FDA 510(k) clearance on 2026-01-26. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K251670.

When did MAC 7 Resting ECG Analysis System receive FDA 510(k) clearance?

MAC 7 Resting ECG Analysis System received FDA 510(k) clearance on 2026-01-26, under 510(k) number K251670.

Who is the listed applicant for MAC 7 Resting ECG Analysis System?

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 MAC 7 Resting ECG Analysis System?

The FDA product code for MAC 7 Resting ECG Analysis System is DPS.

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Weitere Einträge mit Ge Medical Systems Information Technologies, Inc. als Antragsteller

K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P 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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Verwandte Geräte (Code: DPS)

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K252361AccurECG Analyse-System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs Holter PlatformPhilips France Commercial K243252ZBPro DiagnosticZbeats, Inc.

Offizielle Quelle

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