FDA 510(k) clearance · back to tracker

SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES

Leonhard Lang GmbH cleared K103186 on 2011-02-08, decision: substantially equivalent

K-number

K103186

Sponsor

Leonhard Lang GmbH

Device

SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES

Class

Class III

Decision

Substantially Equivalent

Decision date

2011-02-08

Product code

MKJ

Advisory committee

Cardiovascular

Medical specialty

Cardiovascular

Regulation number

870.5310

Official FDA record

Open K103186on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.