Atlas FDA

Sleepiz One+

FDA 510(k) clearance K223163 · decided 2023-08-18

Clearance details

K-number
K223163
Device name
Sleepiz One+
Applicant
Sleepiz AG
Decision
Substantially Equivalent
Date received
2022-10-07
Decision date
2023-08-18
Days to decision
315 days
Clearance type
Traditional
Product code
DRT
Device class
2
Regulation number
870.2300
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Zurich, CH
Third-party review
Yes
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
The Circadia C300 System (C300) (K261286)Circadia Health, Inc.2026-05-20
The Circadia C300 System (C300) (K252676)Circadia Health, Inc.2026-02-03
Sleepiz One+ (Model 2.5) (K253388)Sleepiz AG2026-01-28
Sleepiz One+ (2.5) (K251364)Sleepiz AG2025-07-29
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Neteera 130H-Plus Vital Sign Monitoring Sensor (K231733)Neteera Technologies , Ltd.2024-02-09
Neteera 130H/131H Vital Sign Monitoring Sensor (K212143)Neteera Technologies , Ltd.2022-09-28
Cardiac Trigger Monitor (K202138)Ivy Biomedical Systems, Inc.2021-05-14
Vital Sign Monitoring Sensor (Model :XK300) (K202464)Xandar Kardian, Inc.2021-04-26
Philips wearable biosensor-G5 Solution (K181165)Connected Sensing- A Division of Philips Medical Systems2019-03-07
Vios Monitoring Systemâ„¢ Model 2050 (K172586)Vios Medical, Inc.2018-06-22

Recalls involving this device

No recalls on record reference this clearance.