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)

MEDI-TRACE(R) 500 ECG ELECTRODE

K-Number: K945479 · 1995-07-07

ApplicantGraphic Controls Corp.
Decision Date1995-07-07
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDI-TRACE(R) 500 ECG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Graphic Controls Corp.. It received FDA 510(k) clearance on 1995-07-07 under 510(k) number K945479. The device is classified under product code DRX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDI-TRACE(R) 500 ECG ELECTRODE?

MEDI-TRACE(R) 500 ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1995-07-07. The listed applicant is Graphic Controls Corp.. The 510(k) number is K945479.

When did MEDI-TRACE(R) 500 ECG ELECTRODE receive FDA 510(k) clearance?

MEDI-TRACE(R) 500 ECG ELECTRODE received FDA 510(k) clearance on 1995-07-07, under 510(k) number K945479.

Who is the listed applicant for MEDI-TRACE(R) 500 ECG ELECTRODE?

The FDA 510(k) record lists Graphic Controls Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDI-TRACE(R) 500 ECG ELECTRODE?

The FDA product code for MEDI-TRACE(R) 500 ECG ELECTRODE is DRX.

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 Graphic Controls Corp. 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.

K981964MEDI-TRACE 4103 NEONATAL ELECTRODEK983287MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK974730SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC)K980857MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODEK972970MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODEK964387POINT OF USE II SHARPS-A-GATOR

View all 55 devices →

Related Devices (Code: DRX)

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.

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology CorporationK101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process SasK100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/SK093327INTCO TAB ELECTRODEShanghai Intco Electrode Manufacturing Co., Ltd.

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.

↑