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FDA 510(k)

MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES

K-Number: K863369 · 1987-01-06

ApplicantTdk Corp.
Decision Date1987-01-06
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Tdk Corp.. It received FDA 510(k) clearance on 1987-01-06 under 510(k) number K863369. 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 MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES?

MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES is a medical device that received FDA 510(k) clearance on 1987-01-06. The listed applicant is Tdk Corp.. The 510(k) number is K863369.

When did MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES receive FDA 510(k) clearance?

MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES received FDA 510(k) clearance on 1987-01-06, under 510(k) number K863369.

Who is the listed applicant for MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES?

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

What is the FDA product code for MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES?

The FDA product code for MEL-16-1, MEL-16-3 & MEL-16-5 TDK 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 Tdk 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.

K883643TDK ECG ELECTRODE, MEL-10LK882904TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5K870834TDK ECG ELECTRODE MEL-10K854596TDK ECG ELECTRODE MEL-08-09 & -11K833899TDK ECG ELECTRODE MEL-08

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.

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