510(k) K251364
- Device
- Sleepiz One+ (2.5)
- Applicant
- Sleepiz AG
- 510(k) number
- K251364
- Product code
- DRT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-07-29
- Date received
- 2025-05-01
- Regulation
- 870.2300
- Classification name
- Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Marta Stepien
- Address
- Hornbachstrasse 23 Zurich CH 8008 8008
FDA Registration Numbers
- 3015181391
- 9710602
- 3017760831
- 3014541700
- 3008716327
- 3019388613
- 1062836
- 3014739036
- 3013783488
- 3003832357
- 3026751377
- 3009499478
- 3017986070
- 3004977335
- 1066270
- 3009001657
- 3015997711
- 3017812398
- 9681377
- 3010698831
- 3003294644
- 3030154814
- 3018783526
- 3003800159
- 3043479346
- 3021736577
- 3013596024
- 3013500228
- 3013679558
- 9610816
- 3010703925
- 3014848734
- 3009673645
- 9710654
- 3007836437
- 3005877899
- 1221108
- 3008483389
- 3013826848
- 3016852448
- 3009607734
- 3015282442
- 3003589956
- 3008460104
- 3005521864
- 3003263092
- 3016931915
- 3021343210
- 3007413079
- 1220908
- 3017422354
- 3007603826
- 3029871637
- 3008717264
- 2118418
- 3023272766
- 3009831876
- 3003803088
- 3004415095
- 3012359877
- 1651104
- 3003971136
- 3012104670
- 3012238587
- 3015328411
- 3009077524
- 3016618143
- 3021559257
- 3010536822
- 1218950
- 9611252
- 3007305624
- 3011353843
- 3005783425
- 1527715
- 3012494290
- 3032109181
- 3000126629
- 1219324
- 1319390
Source Documents
Other 510(k) Records For Product Code DRT
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261286 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-05-20 |
| K252676 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026-02-03 |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | 2026-01-28 |
| K234003 | The Circadia C200 System | Circadia Technologies, Ltd. | 2024-05-30 |
| K232354 | Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software | Murata Vios, Inc. | 2024-03-22 |
| K231733 | Neteera 130H-Plus Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2024-02-09 |
| K223163 | Sleepiz One+ | Sleepiz AG | 2023-08-18 |
| K212143 | Neteera 130H/131H Vital Sign Monitoring Sensor | Neteera Technologies , Ltd. | 2022-09-28 |
| K202138 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2021-05-14 |
| K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021-04-26 |
| K181165 | Philips wearable biosensor-G5 Solution | Connected Sensing- A Division of Philips Medical Systems | 2019-03-07 |
| K172586 | Vios Monitoring System™ Model 2050 | Vios Medical, Inc. | 2018-06-22 |
| K170828 | Cardiac Trigger Monitor | Ivy Biomedical Systems, Inc. | 2017-05-17 |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | Ivy Biomedical Systems, Inc. | 2016-05-27 |
| K150992 | Vios Monitoring System | Vios Medical, Inc. | 2015-12-16 |