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FDA 510(k)

TDK ECG ELECTRODE, MEL-10L

K-Number: K883643 · 1988-11-17

ApplicantTdk Corp.
Decision Date1988-11-17
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TDK ECG ELECTRODE, MEL-10L is the device name listed in this FDA 510(k) record. The listed applicant is Tdk Corp.. It received FDA 510(k) clearance on 1988-11-17 under 510(k) number K883643. 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 TDK ECG ELECTRODE, MEL-10L?

TDK ECG ELECTRODE, MEL-10L is a medical device that received FDA 510(k) clearance on 1988-11-17. The listed applicant is Tdk Corp.. The 510(k) number is K883643.

When did TDK ECG ELECTRODE, MEL-10L receive FDA 510(k) clearance?

TDK ECG ELECTRODE, MEL-10L received FDA 510(k) clearance on 1988-11-17, under 510(k) number K883643.

Who is the listed applicant for TDK ECG ELECTRODE, MEL-10L?

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 TDK ECG ELECTRODE, MEL-10L?

The FDA product code for TDK ECG ELECTRODE, MEL-10L 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.

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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.

K882904TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5K870834TDK ECG ELECTRODE MEL-10K863369MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODESK854596TDK 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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