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FDA 510(k)

TDK ECG ELECTRODE MEL-08-09 & -11

K-Number: K854596 · 1986-05-07

ApplicantTdk Corp.
Decision Date1986-05-07
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TDK ECG ELECTRODE MEL-08-09 & -11 is the device name listed in this FDA 510(k) record. The listed applicant is Tdk Corp.. It received FDA 510(k) clearance on 1986-05-07 under 510(k) number K854596. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TDK ECG ELECTRODE MEL-08-09 & -11?

TDK ECG ELECTRODE MEL-08-09 & -11 is a medical device that received FDA 510(k) clearance on 1986-05-07. The listed applicant is Tdk Corp.. The 510(k) number is K854596.

When did TDK ECG ELECTRODE MEL-08-09 & -11 receive FDA 510(k) clearance?

TDK ECG ELECTRODE MEL-08-09 & -11 received FDA 510(k) clearance on 1986-05-07, under 510(k) number K854596.

Who is the listed applicant for TDK ECG ELECTRODE MEL-08-09 & -11?

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-08-09 & -11?

The FDA product code for TDK ECG ELECTRODE MEL-08-09 & -11 is DRS.

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.

K883643TDK ECG ELECTRODE, MEL-10LK882904TDK ELECTRODE MEL-20-1, MEL-20-3, MEL-20-5K870834TDK ECG ELECTRODE MEL-10K863369MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODESK833899TDK ECG ELECTRODE MEL-08

Related Devices (Code: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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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