Sleepiz One+
K-Number: K223163 · 2023-08-18
ApplicantSleepiz AG
Decision Date2023-08-18
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Sleepiz One+ is a medical device manufactured by Sleepiz AG. It received FDA 510(k) clearance on 2023-08-18 under approval number K223163. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sleepiz One+?
Sleepiz One+ is a medical device that received FDA 510(k) clearance on 2023-08-18. It is manufactured by Sleepiz AG. The 510(k) number is K223163.
When was Sleepiz One+ approved by the FDA?
Sleepiz One+ received FDA 510(k) clearance on 2023-08-18, under approval number K223163.
What company makes Sleepiz One+?
Sleepiz One+ is manufactured by Sleepiz AG.
What is the FDA product code for Sleepiz One+?
The FDA product code for Sleepiz One+ is DRT.
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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.