GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES— 510(k) K945676

Name: FDA 510(k) clearance K945676
Creator: U.S. Food and Drug Administration
Published: 1995-01-30

Substantially Equivalent

Selectivemed Components, Inc.

FDA 510(k) clearance K945676 for GUARDIAN DISPOSABLE TENS AND TENS/NMES ELECTRODES, Substantially Equivalent on 1995-01-30. Applicant: Selectivemed Components, Inc.. Device class: 2.

Clearance details

Applicant: Selectivemed Components, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1994-11-18
Decision date: 1995-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mt. Vernon, OH, US

Download summary PDF View on FDA.gov ↗

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