WYLER SUBDURAL STRIP ELECTRODE— 510(k) K850342

Name: FDA 510(k) clearance K850342
Creator: U.S. Food and Drug Administration
Published: 1985-07-30

Substantially Equivalent for Some Indications

Ad-Tech Medical Instrument Corp

FDA 510(k) clearance K850342 for WYLER SUBDURAL STRIP ELECTRODE, Substantially Equivalent for Some Indications on 1985-07-30. Applicant: Ad-Tech Medical Instrument Corp. Device class: 2.

Clearance details

Applicant: Ad-Tech Medical Instrument Corp
Product code: Code GYC
Device class: Class 2
Regulation: 21 CFR 882.1310
Advisory panel: Neurology
Date received: 1985-01-28
Decision date: 1985-07-30
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Racine, WI, US

Download summary PDF View on FDA.gov ↗

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