Diacare 7000— 510(k) K211207

Name: FDA 510(k) clearance K211207
Creator: U.S. Food and Drug Administration
Published: 2022-06-06

Substantially Equivalent

Globus Sport and Health Technologies, LLC

FDA 510(k) clearance K211207 for Diacare 7000, Substantially Equivalent on 2022-06-06. Applicant: Globus Sport and Health Technologies, LLC. Device class: 2.

Clearance details

Applicant: Globus Sport and Health Technologies, LLC
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2021-04-22
Decision date: 2022-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.