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FDA 510(k)

SKINTACT AG ELECTRODES

K-Number: K862618 · 1986-09-15

ApplicantLeon H. Lang Co.
Decision Date1986-09-15
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SKINTACT AG ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Leon H. Lang Co.. It received FDA 510(k) clearance on 1986-09-15 under 510(k) number K862618. 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 SKINTACT AG ELECTRODES?

SKINTACT AG ELECTRODES is a medical device that received FDA 510(k) clearance on 1986-09-15. The listed applicant is Leon H. Lang Co.. The 510(k) number is K862618.

When did SKINTACT AG ELECTRODES receive FDA 510(k) clearance?

SKINTACT AG ELECTRODES received FDA 510(k) clearance on 1986-09-15, under 510(k) number K862618.

Who is the listed applicant for SKINTACT AG ELECTRODES?

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

What is the FDA product code for SKINTACT AG ELECTRODES?

The FDA product code for SKINTACT AG ELECTRODES is DRX.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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