DUPEL II BUFFERED IONTOPHORESIS ELECTRODES— 510(k) K970491

Name: FDA 510(k) clearance K970491
Creator: U.S. Food and Drug Administration
Published: 1997-05-30

Substantially Equivalent

Empi

FDA 510(k) clearance K970491 for DUPEL II BUFFERED IONTOPHORESIS ELECTRODES, Substantially Equivalent on 1997-05-30. Applicant: Empi. Device class: 2.

Clearance details

Applicant: Empi
Product code: Code EGJ
Device class: Class 2
Regulation: 21 CFR 890.5525
Advisory panel: Physical Medicine
Date received: 1997-02-10
Decision date: 1997-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.