FDA 510(k)

ELECTROCARDIOGRAPH ELECTRODE

K-Number: K801846 · 1980-09-09

Decision Date1980-09-09

Product CodeDRX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ELECTROCARDIOGRAPH ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Glove Co.. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801846. 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 ELECTROCARDIOGRAPH ELECTRODE?

ELECTROCARDIOGRAPH ELECTRODE is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Phoenix Glove Co.. The 510(k) number is K801846.

When did ELECTROCARDIOGRAPH ELECTRODE receive FDA 510(k) clearance?

ELECTROCARDIOGRAPH ELECTRODE received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801846.

Who is the listed applicant for ELECTROCARDIOGRAPH ELECTRODE?

The FDA 510(k) record lists Phoenix Glove Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELECTROCARDIOGRAPH ELECTRODE?

The FDA product code for ELECTROCARDIOGRAPH 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Phoenix Glove Co. as applicant

K830660STERILE SURGICAL DRAPES K821044PATIENT PREP KITS/TRAYS-STERILE K821666STERILE SURGICAL DRAPES K821043STERILE PATIENT EXAM. GLOVES K781820GLOVES, VINYL EXAMINATION

Related Devices (Code: DRX)

K171244PhysiotraceNimbleheart, Inc.K123658BIOMODULE 3-M1Zephyr Technology Corporation K101576CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODESTeam Innovations, Inc.K101685IP-SETIntegral Process Sas K100129AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO XAmbu A/S K093327INTCO 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.