Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM

K-Number: K042177 · 2004-08-27

ApplicantGe Medical Systems Information Technologies
Decision Date2004-08-27
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 2004-08-27 under 510(k) number K042177. 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 5000 ECG ANALYSIS SYSTEM?

MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-27. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K042177.

When did MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM received FDA 510(k) clearance on 2004-08-27, under 510(k) number K042177.

Who is the listed applicant for MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM?

The FDA 510(k) record lists Ge Medical 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 5000 ECG ANALYSIS SYSTEM?

The FDA product code for MODIFICATION TO MAC 5000 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ge Medical Systems Information Technologies as applicant

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.

K120770QT GUARD PLUS ANALYSIS SYSTEMK102426CARESCAPE MODEL V100 VITAL SIGNS MONITORK09236912SL ECG ANALYSIS PROGRAMK093141MARS HOLTER ANALYSIS WORKSTATIONK092027CARESCAPE MONITOR B850K090702MODIFICATION TO DASH 2500 PATIENT MONITOR

View all 136 devices →

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.

↑