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FDA 510(k)

EK12 V2 Algorithm

K-Number: K221904 · 2022-12-20

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2022-12-20
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EK12 V2 Algorithm 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 2022-12-20 under 510(k) number K221904. 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 EK12 V2 Algorithm?

EK12 V2 Algorithm is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K221904.

When did EK12 V2 Algorithm receive FDA 510(k) clearance?

EK12 V2 Algorithm received FDA 510(k) clearance on 2022-12-20, under 510(k) number K221904.

Who is the listed applicant for EK12 V2 Algorithm?

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 EK12 V2 Algorithm?

The FDA product code for EK12 V2 Algorithm is MHX.

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

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Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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