Data / Medical devices / Switzerland / Sleepiz AG
Sleepiz AG: FDA-registered device maker in Zurich, Switzerland, 2 510(k) clearances
Sleepiz AG is registered with the FDA (registration 3020207731) in Zurich, Switzerland. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020207731
- Address
- Hornbachstrasse 23, Zurich, Switzerland, 8008
- Owner or operator
- Sleepiz AG (10083842)
- Roles
- Manufacturer, Specification developer
- First device listed
- December 25, 2021
- Registered through
- 2026
- Brand names listed
- Sleepiz One+, Sleepiz One+ (Hardware Model 2.5)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Breathing Frequency | BZQ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Oscillometer | DRZ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 29, 2025 | K251364 | Sleepiz One+ (2.5) | DRT | Substantially Equivalent | Sleepiz AG | accessdata.fda.gov |
| August 18, 2023 | K223163 | Sleepiz One+ | DRT | Substantially Equivalent | Sleepiz AG | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Breathing Frequency
- All makers of Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- All makers of Oscillometer
Updated July 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.