KidCap— 510(k) K180568

Substantially Equivalent

Eastern Cranial Affiliates, LLC

FDA 510(k) clearance K180568 for KidCap, Substantially Equivalent on 2018-10-16. Applicant: Eastern Cranial Affiliates, LLC. Device class: 2.

Clearance details

Applicant: Eastern Cranial Affiliates, LLC
Product code: Code MVA
Device class: Class 2
Regulation: 21 CFR 882.5970
Advisory panel: Neurology
Date received: 2018-03-05
Decision date: 2018-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfax, VA, 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.