510(k) K253388

Sleepiz One+ (Model 2.5) by Sleepiz AG — Product Code DRT

K253388 is an FDA 510(k) premarket notification submitted by Sleepiz AG for the device "Sleepiz One+ (Model 2.5)". The FDA issued a decision of Substantially Equivalent on January 28, 2026. The device falls under product code DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)), a Class II device regulated under 21 CFR 870.2300. Sleepiz AG has at least 2 other 510(k) clearances on record.