RECORDING AND STIMULATING ELECTRODE— 510(k) K012850

Name: FDA 510(k) clearance K012850
Creator: U.S. Food and Drug Administration
Published: 2001-11-19

Substantially Equivalent

Radionics, A Division of Tyco Healthcare Group LP

FDA 510(k) clearance K012850 for RECORDING AND STIMULATING ELECTRODE, Substantially Equivalent on 2001-11-19. Applicant: Radionics, A Division of Tyco Healthcare Group LP. Device class: 2.

Clearance details

Applicant: Radionics, A Division of Tyco Healthcare Group LP
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2001-08-24
Decision date: 2001-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burlington, MA, US

Download summary PDF View on FDA.gov ↗

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