STAODYN MAX PRESET, MODEL 4470— 510(k) K061516

Name: FDA 510(k) clearance K061516
Creator: U.S. Food and Drug Administration
Published: 2007-02-06

Substantially Equivalent

Compex Technologies, Inc.

FDA 510(k) clearance K061516 for STAODYN MAX PRESET, MODEL 4470, Substantially Equivalent on 2007-02-06. Applicant: Compex Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Compex Technologies, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2006-06-01
Decision date: 2007-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brighton, MN, US

Download summary PDF View on FDA.gov ↗

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