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FDA 510(k)

Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P

K-Number: K213490 · 2022-04-01

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2022-04-01
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2022-04-01 under approval number K213490. 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 2022-04-01. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K213490.

When was Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P approved by the FDA?

Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P received FDA 510(k) clearance on 2022-04-01, under approval number K213490.

What company makes Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P?

Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P is manufactured by Ge Medical Systems Information Technologies, Inc..

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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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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