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FDA 510(k)

800 ECG ELECTRODE

K-Number: K790507 · 1979-05-18

ApplicantSimonsen & Weels Eftf.
Decision Date1979-05-18
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

800 ECG ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Simonsen & Weels Eftf.. It received FDA 510(k) clearance on 1979-05-18 under 510(k) number K790507. 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 800 ECG ELECTRODE?

800 ECG ELECTRODE is a medical device that received FDA 510(k) clearance on 1979-05-18. The listed applicant is Simonsen & Weels Eftf.. The 510(k) number is K790507.

When did 800 ECG ELECTRODE receive FDA 510(k) clearance?

800 ECG ELECTRODE received FDA 510(k) clearance on 1979-05-18, under 510(k) number K790507.

Who is the listed applicant for 800 ECG ELECTRODE?

The FDA 510(k) record lists Simonsen & Weels Eftf. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 800 ECG ELECTRODE?

The FDA product code for 800 ECG 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.

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Other records listing Simonsen & Weels Eftf. 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.

K790506DAISCOPE & ACCESSORIES

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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