SOMNUM (V.1.1.2.)
K-Number: K223922 · 2023-08-16
ApplicantHoneynaps Co., Ltd.
Decision Date2023-08-16
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
SOMNUM (V.1.1.2.) is a medical device manufactured by Honeynaps Co., Ltd.. It received FDA 510(k) clearance on 2023-08-16 under approval number K223922. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SOMNUM (V.1.1.2.)?
SOMNUM (V.1.1.2.) is a medical device that received FDA 510(k) clearance on 2023-08-16. It is manufactured by Honeynaps Co., Ltd.. The 510(k) number is K223922.
When was SOMNUM (V.1.1.2.) approved by the FDA?
SOMNUM (V.1.1.2.) received FDA 510(k) clearance on 2023-08-16, under approval number K223922.
What company makes SOMNUM (V.1.1.2.)?
SOMNUM (V.1.1.2.) is manufactured by Honeynaps Co., Ltd..
What is the FDA product code for SOMNUM (V.1.1.2.)?
The FDA product code for SOMNUM (V.1.1.2.) is OLZ.
Related Devices (Code: OLZ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.