AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)— 510(k) K861014

Name: FDA 510(k) clearance K861014
Creator: U.S. Food and Drug Administration
Published: 1986-08-20

Substantially Equivalent

Amplaid USA, Inc.

FDA 510(k) clearance K861014 for AMPLAID MK15 (EVOKED POTENTIAL SYSTEM), Substantially Equivalent on 1986-08-20. Applicant: Amplaid USA, Inc.. Device class: 2.

Clearance details

Applicant: Amplaid USA, Inc.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 1986-03-18
Decision date: 1986-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rolling Meadows, IL, US

Download summary PDF View on FDA.gov ↗

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