LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)— 510(k) K863135

Name: FDA 510(k) clearance K863135
Creator: U.S. Food and Drug Administration
Published: 1987-09-04

Substantially Equivalent

Neurotechnics, Inc.

FDA 510(k) clearance K863135 for LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP), Substantially Equivalent on 1987-09-04. Applicant: Neurotechnics, Inc.. Device class: 2.

Clearance details

Applicant: Neurotechnics, Inc.
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 1986-08-15
Decision date: 1987-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Annapolis, MD, US

Download summary PDF View on FDA.gov ↗

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