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FDA 510(k)

MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM

K-Number: K073625 · 2008-01-25

ApplicantGe Healthcare Systems Information Technologies
Decision Date2008-01-25
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Healthcare Systems Information Technologies. It received FDA 510(k) clearance on 2008-01-25 under 510(k) number K073625. 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 MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM?

MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2008-01-25. The listed applicant is Ge Healthcare Systems Information Technologies. The 510(k) number is K073625.

When did MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM received FDA 510(k) clearance on 2008-01-25, under 510(k) number K073625.

Who is the listed applicant for MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM?

The FDA 510(k) record lists Ge Healthcare Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM?

The FDA product code for MODIFICATION TO: MAC 5500 RESTING ECG ANALYSIS SYSTEM is DPS.

Related Clinical Trials

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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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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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