Medical Device Manufacturer · CH , Zurich

Sleepiz AG - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2023

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sleepiz AG Cardiovascular ✕

3 devices

1-3 of 3

Cleared Jan 28, 2026

Sleepiz One+ (Model 2.5)

Cardiovascular · 120d

Cleared Jul 29, 2025

Sleepiz One+ (2.5)

Cardiovascular · 89d

Cleared Aug 18, 2023

Cardiovascular · 315d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: Apr 27, 2026