FDA 510(k)

MAC 600 RESTING ECG ANALYSIS SYSTEM

K-Number: K103765 · 2011-05-17

ApplicantGe Medical Systems Information Technologies, Inc.

Decision Date2011-05-17

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MAC 600 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 2011-05-17 under 510(k) number K103765. 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 600 RESTING ECG ANALYSIS SYSTEM?

MAC 600 RESTING ECG ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2011-05-17. The listed applicant is Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K103765.

When did MAC 600 RESTING ECG ANALYSIS SYSTEM receive FDA 510(k) clearance?

MAC 600 RESTING ECG ANALYSIS SYSTEM received FDA 510(k) clearance on 2011-05-17, under 510(k) number K103765.

Who is the listed applicant for MAC 600 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 600 RESTING ECG ANALYSIS SYSTEM?

The FDA product code for MAC 600 RESTING ECG ANALYSIS SYSTEM is DPS.

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

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Related Devices (Code: DPS)

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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.