COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH— 510(k) K013507

Name: FDA 510(k) clearance K013507
Creator: U.S. Food and Drug Administration
Published: 2002-01-25

Substantially Equivalent

Cosmo Health, Inc.

FDA 510(k) clearance K013507 for COSMO TENS PF-990 MINI DIGITAL WIRELESS PATCH, Substantially Equivalent on 2002-01-25. Applicant: Cosmo Health, Inc.. Device class: 2.

Clearance details

Applicant: Cosmo Health, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2001-10-22
Decision date: 2002-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Caldwell, NJ, US

Download summary PDF View on FDA.gov ↗

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