FDA 510(k)

Sleepiz One+

K-Number: K223163 · 2023-08-18

Decision Date2023-08-18

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Sleepiz One+ is the device name listed in this FDA 510(k) record. The listed applicant is Sleepiz AG. It received FDA 510(k) clearance on 2023-08-18 under 510(k) 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. The listed applicant is Sleepiz AG. The 510(k) number is K223163.

When did Sleepiz One+ receive FDA 510(k) clearance?

Sleepiz One+ received FDA 510(k) clearance on 2023-08-18, under 510(k) number K223163.

Who is the listed applicant for Sleepiz One+?

The FDA 510(k) record lists Sleepiz AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sleepiz One+?

The FDA product code for Sleepiz One+ is DRT.

Other records listing Sleepiz AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253388Sleepiz One+ (Model 2.5)K251364Sleepiz One+ (2.5)

Related Devices (Code: DRT)

K261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AG K251364Sleepiz One+ (2.5)Sleepiz AG K234003The Circadia C200 SystemCircadia Technologies, Ltd.K232354Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server SoftwareMurata Vios, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.