iCE-SG2 Subcutaneous Electrode Kit— 510(k) K222706

Name: FDA 510(k) clearance K222706
Creator: U.S. Food and Drug Administration
Published: 2022-12-06

Substantially Equivalent

Ice Neurosystems, Inc.

FDA 510(k) clearance K222706 for iCE-SG2 Subcutaneous Electrode Kit, Substantially Equivalent on 2022-12-06. Applicant: Ice Neurosystems, Inc.. Device class: 2.

Clearance details

Applicant: Ice Neurosystems, Inc.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2022-09-07
Decision date: 2022-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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