Spes Medica Subdermal Needle Electrodes— 510(k) K192603

Name: FDA 510(k) clearance K192603
Creator: U.S. Food and Drug Administration
Published: 2019-11-22

Substantially Equivalent

Spes Medica Srl

FDA 510(k) clearance K192603 for Spes Medica Subdermal Needle Electrodes, Substantially Equivalent on 2019-11-22. Applicant: Spes Medica Srl. Device class: 2.

Clearance details

Applicant: Spes Medica Srl
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 2019-09-20
Decision date: 2019-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Battipaglia (Sa), IT

Download summary PDF View on FDA.gov ↗

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