DeviceClearance

Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P— 510(k) K253277

Substantially Equivalent

Ge Medical Systems Information Technologies, Inc.

FDA 510(k) clearance K253277 for Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P, Substantially Equivalent on 2026-07-24. Applicant: Ge Medical Systems Information Technologies, Inc.. Device class: 2.

Summary

GE Medical Systems Information Technologies' clearance covers five patient monitors: B105M, B125M, B155M, B105P, and B125P. They're filed under MHX, physiological patient monitors with arrhythmia detection or alarms, and the record doesn't say how the models differ.

Class II, 21 CFR 870.1025. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).

GE filed from Wauwatosa, Wisconsin. The decision came 298 calendar days after FDA received it (September 29, 2025 to July 24, 2026).

Clearance details

Applicant
Ge Medical Systems Information Technologies, Inc.
Product code
Product code MHX
Device class
Class 2
Regulation
21 CFR 870.1025
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wauwatosa, WI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code MHX

product code MHX
Death
580
Injury
2,441
Malfunction
12,655
Other
3
Total
15,679

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.