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FDA 510(k)

MAC 7 Resting ECG Analysis System

K-Number: K251670 · 2026-01-26

ApplicantGe Medical Systems Information Technologies, Inc.
Decision Date2026-01-26
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MAC 7 Resting ECG Analysis System 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 2026-01-26 under 510(k) number K251670. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAC 7 Resting ECG Analysis System?

MAC 7 Resting ECG Analysis System is a medical device that received FDA 510(k) clearance on 2026-01-26. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K251670.

When did MAC 7 Resting ECG Analysis System receive FDA 510(k) clearance?

MAC 7 Resting ECG Analysis System received FDA 510(k) clearance on 2026-01-26, under 510(k) number K251670.

Who is the listed applicant for MAC 7 Resting ECG Analysis System?

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 MAC 7 Resting ECG Analysis System?

The FDA product code for MAC 7 Resting ECG Analysis System is DPS.

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

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Related Devices (Code: DPS)

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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