Cleared Traditional

Sleepiz One+

K223163 · Sleepiz AG · Cardiovascular

Aug 2023

Decision

315d

Days

Class 2

Risk

About This 510(k) Submission

K223163 is an FDA 510(k) clearance for the Sleepiz One+, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Sleepiz AG (Zurich, CH). The FDA issued a Cleared decision on August 18, 2023, 315 days after receiving the submission on October 7, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K223163 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 07, 2022
Decision Date	August 18, 2023
Days to Decision	315 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF