AXION 5, MODIFICATION— 510(k) K911814

Name: FDA 510(k) clearance K911814
Creator: U.S. Food and Drug Administration
Published: 1991-10-15

Substantially Equivalent

Ventura Medical Electronics

FDA 510(k) clearance K911814 for AXION 5, MODIFICATION, Substantially Equivalent on 1991-10-15. Applicant: Ventura Medical Electronics. Device class: 2.

Clearance details

Applicant: Ventura Medical Electronics
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1991-04-17
Decision date: 1991-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Merriam, KS, US

Download summary PDF View on FDA.gov ↗

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