QBioScan

Device, Galvanic Skin Response Measurement

MEDEIA, INC.

The following data is part of a premarket notification filed by Medeia, Inc. with the FDA for Qbioscan.

Pre-market Notification Details

Device IDK150804
510k NumberK150804
Device Name:QBioScan
ClassificationDevice, Galvanic Skin Response Measurement
Applicant MEDEIA, INC. 80 S. W. 8TH ST. SUITE 200 Miami,  FL  33130
ContactSlav Danev
CorrespondentDaniel Lehtonen
COMPLIANCE AND REGULATORY SERVICES LLC 3771 SOUTHBROOK DR Dayton,  OH  45430
Product CodeGZO  
CFR Regulation Number882.1540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-26
Decision Date2015-10-19
Summary:summary

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