Sleepiz One+— 510(k) K223163

Substantially Equivalent

Sleepiz AG

FDA 510(k) clearance K223163 for Sleepiz One+, Substantially Equivalent on 2023-08-18. Applicant: Sleepiz AG.

Clearance details

Applicant: Sleepiz AG
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2022-10-07
Decision date: 2023-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zurich, CH

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.