FDA.report

510(k) K223922

Device
SOMNUM (V.1.1.2.)
Applicant
Honeynaps Co., Ltd.
510(k) number
K223922
Product code
OLZ
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-16
Date received
2022-12-30
Regulation
882.1400
Classification name
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Tony Lee
Address
4f, Marine Tech B/D, 529, Nonhyeon-Ro, Gangnam-Gu Seoul KR 06126 06126

FDA Registration Numbers

Source Documents

510(k) summary PDF

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