QBioScan— 510(k) K150804

Substantially Equivalent

Medeia, Inc.

FDA 510(k) clearance K150804 for QBioScan, Substantially Equivalent on 2015-10-19. Applicant: Medeia, Inc.. Device class: 2.

Clearance details

Applicant: Medeia, Inc.
Product code: Code GZO
Device class: Class 2
Regulation: 21 CFR 882.1540
Advisory panel: Neurology
Date received: 2015-03-26
Decision date: 2015-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZO

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K141872 — SUDOSCAN2014-11-21
K131568 — SUDO PATH2013-06-28
K111308 — ZYTO HAND CRADLE2011-08-30
K102166 — ELECTRO INTERSTITIAL SCAN2010-12-10

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Data sourced from openFDA. This site is unofficial and independent of the FDA.