Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE

K-Number: K080106 · 2008-02-01

ApplicantLeonhard Lang GmbH
Decision Date2008-02-01
Product CodeDRX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE 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 2008-02-01 under 510(k) number K080106. 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 PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE?

SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE is a medical device that received FDA 510(k) clearance on 2008-02-01. The listed applicant is Leonhard Lang GmbH. The 510(k) number is K080106.

When did SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE receive FDA 510(k) clearance?

SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE received FDA 510(k) clearance on 2008-02-01, under 510(k) number K080106.

Who is the listed applicant for SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE?

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 PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE?

The FDA product code for SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVE 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 ELECTRODESK092291SKINTACT AND VARIOUS OTHER TRADENAMESK081371SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GELK073104SKINTACT 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

View all 14 devices →

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.

↑