Chrysalis Intelligence
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Sponsors
· Sleepiz AG
Sleepiz AG
Zurich, CH · 3 510(k) clearances
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Total clearances
3
2023-08-18 → 2026-01-28
Last 12 months
1
Product codes
1
Most recent
2026-01-28
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Product codes
worked
Code
Device name
Class
Specialty
Clearances
Most recent
DRT
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Class II
Cardiovascular
3
2026-01-28
Filings
All 510(k) clearances
(3)
Date
K-number
Device
Code
Class
Specialty
2026-01-28
K253388
Sleepiz One+ (Model 2.5)
DRT
Class II
Cardiovascular
2025-07-29
K251364
Sleepiz One+ (2.5)
DRT
Class II
Cardiovascular
2023-08-18
K223163
Sleepiz One+
DRT
Class II
Cardiovascular