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FDA 510(k)

SKINTACT AND VARIOUS OTHER TRADENAMES

K-Number: K092291 · 2009-08-21

ApplicantLeonhard Lang GmbH
Decision Date2009-08-21
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SKINTACT AND VARIOUS OTHER TRADENAMES is the device name listed in this FDA 510(k) record. The listed applicant is Leonhard Lang GmbH. It received FDA 510(k) clearance on 2009-08-21 under 510(k) number K092291. 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 AND VARIOUS OTHER TRADENAMES?

SKINTACT AND VARIOUS OTHER TRADENAMES is a medical device that received FDA 510(k) clearance on 2009-08-21. The listed applicant is Leonhard Lang GmbH. The 510(k) number is K092291.

When did SKINTACT AND VARIOUS OTHER TRADENAMES receive FDA 510(k) clearance?

SKINTACT AND VARIOUS OTHER TRADENAMES received FDA 510(k) clearance on 2009-08-21, under 510(k) number K092291.

Who is the listed applicant for SKINTACT AND VARIOUS OTHER TRADENAMES?

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

What is the FDA product code for SKINTACT AND VARIOUS OTHER TRADENAMES?

The FDA product code for SKINTACT AND VARIOUS OTHER TRADENAMES is DRX.

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Other records listing Leonhard Lang GmbH 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.

K103186SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODESK081371SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GELK080106SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVEK073104SKINTACT AND VARIOUS OTHER TRADENAMESK072233SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFERENT CONNECTORS COMPATIBLE WITH DIFFERENT DEFIBRILLATORSK063161SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL

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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

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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