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)

MEDICOTEST ECG ELECTRODES

K-Number: K961643 · 1996-12-09

ApplicantMedicotest, Inc.
Decision Date1996-12-09
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDICOTEST ECG ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Medicotest, Inc.. It received FDA 510(k) clearance on 1996-12-09 under 510(k) number K961643. 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 MEDICOTEST ECG ELECTRODES?

MEDICOTEST ECG ELECTRODES is a medical device that received FDA 510(k) clearance on 1996-12-09. The listed applicant is Medicotest, Inc.. The 510(k) number is K961643.

When did MEDICOTEST ECG ELECTRODES receive FDA 510(k) clearance?

MEDICOTEST ECG ELECTRODES received FDA 510(k) clearance on 1996-12-09, under 510(k) number K961643.

Who is the listed applicant for MEDICOTEST ECG ELECTRODES?

The FDA 510(k) record lists Medicotest, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDICOTEST ECG ELECTRODES?

The FDA product code for MEDICOTEST ECG ELECTRODES 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 Medicotest, Inc. 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.

K983597NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODESK970639NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-KK952176DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-KK941568K-10-VS, DA-05-VS, RECORDING ELECTRODESK931426NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODEK931430CUTANEOUS ELECTRODE

View all 14 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.

↑