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FDA 510(k)

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

K-Number: K253277 · 2026-07-24

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2026-07-24
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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 2026-07-24 under 510(k) number K253277. 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 2026-07-24. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K253277.

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 2026-07-24, under 510(k) number K253277.

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.

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

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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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