NEUROPACE BURR HOLE COVER MODEL 8110— 510(k) K123163

Name: FDA 510(k) clearance K123163
Creator: U.S. Food and Drug Administration
Published: 2013-01-18

Substantially Equivalent

NeuroPace, Inc.

FDA 510(k) clearance K123163 for NEUROPACE BURR HOLE COVER MODEL 8110, Substantially Equivalent on 2013-01-18. Applicant: NeuroPace, Inc.. Device class: 2.

Clearance details

Applicant: NeuroPace, Inc.
Product code: Code GXR
Device class: Class 2
Regulation: 21 CFR 882.5250
Advisory panel: Neurology
Date received: 2012-10-09
Decision date: 2013-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

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