GLOBALCARE MICRO 11 AND MICROCARE (TENS)— 510(k) K903394

Name: FDA 510(k) clearance K903394
Creator: U.S. Food and Drug Administration
Published: 1991-05-06

Substantially Equivalent

Globalcare Intl., Inc.

FDA 510(k) clearance K903394 for GLOBALCARE MICRO 11 AND MICROCARE (TENS), Substantially Equivalent on 1991-05-06. Applicant: Globalcare Intl., Inc.. Device class: 2.

Clearance details

Applicant: Globalcare Intl., Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1990-07-27
Decision date: 1991-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holyoke, MA, 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.