SENSOSEEG Depth Electrodes— 510(k) K213170

Name: FDA 510(k) clearance K213170
Creator: U.S. Food and Drug Administration
Published: 2023-04-18

Substantially Equivalent

Sensomedical Labs, Ltd.

FDA 510(k) clearance K213170 for SENSOSEEG Depth Electrodes, Substantially Equivalent on 2023-04-18. Applicant: Sensomedical Labs, Ltd.. Device class: 2.

Clearance details

Applicant: Sensomedical Labs, Ltd.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2021-09-28
Decision date: 2023-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nazareth, IL

Download summary PDF View on FDA.gov ↗

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