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FDA 510(k)

Monitor B125, Monitor B105

K-Number: K201941 · 2020-11-04

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2020-11-04
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Monitor B125, Monitor B105 is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2020-11-04 under approval number K201941. 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 B125, Monitor B105?

Monitor B125, Monitor B105 is a medical device that received FDA 510(k) clearance on 2020-11-04. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K201941.

When was Monitor B125, Monitor B105 approved by the FDA?

Monitor B125, Monitor B105 received FDA 510(k) clearance on 2020-11-04, under approval number K201941.

What company makes Monitor B125, Monitor B105?

Monitor B125, Monitor B105 is manufactured by Ge Medical Systems Information Technologies, Inc..

What is the FDA product code for Monitor B125, Monitor B105?

The FDA product code for Monitor B125, Monitor B105 is MHX.

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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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