Tech Dots - Adhesive and conductive gel— 510(k) K190050

Name: FDA 510(k) clearance K190050
Creator: U.S. Food and Drug Administration
Published: 2019-07-19

Substantially Equivalent

Spes Medica Srl

FDA 510(k) clearance K190050 for Tech Dots - Adhesive and conductive gel, Substantially Equivalent on 2019-07-19. Applicant: Spes Medica Srl. Device class: 2.

Clearance details

Applicant: Spes Medica Srl
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 2019-01-10
Decision date: 2019-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Battipaglia (Sa), IT

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.