SOMNUM (V.1.1.2.)— 510(k) K223922

Substantially Equivalent

Honeynaps Co., Ltd.

FDA 510(k) clearance K223922 for SOMNUM (V.1.1.2.), Substantially Equivalent on 2023-08-16. Applicant: Honeynaps Co., Ltd.. Device class: 2.

Clearance details

Applicant: Honeynaps Co., Ltd.
Product code: Code OLZ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2022-12-30
Decision date: 2023-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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