CLARREN HELMET— 510(k) K003035

Name: FDA 510(k) clearance K003035
Creator: U.S. Food and Drug Administration
Published: 2001-06-06

Substantially Equivalent

Children'S Hospital & Medical Center

FDA 510(k) clearance K003035 for CLARREN HELMET, Substantially Equivalent on 2001-06-06. Applicant: Children'S Hospital & Medical Center. Device class: 2.

Clearance details

Applicant: Children'S Hospital & Medical Center
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2000-09-28
Decision date: 2001-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.