CRANIAL HELMET— 510(k) K013458

Substantially Equivalent

Children'S Hospital

FDA 510(k) clearance K013458 for CRANIAL HELMET, Substantially Equivalent on 2001-10-29. Applicant: Children'S Hospital. Device class: 2.

Clearance details

Applicant: Children'S Hospital
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2001-10-18
Decision date: 2001-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, 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.