ANNE One
FDA 510(k) K223711 · Sibel Health, Inc.
510(k) numberK223711
Submission
- Device name
- ANNE One
- Applicant
- Sibel Health, Inc.
Niles, IL, US - Received
- December 12, 2022
- Decision date
- August 10, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261569 | UbiqVue 2AYe Cardiac System (UX2253)DRG · Traditional | Lifesignals, Inc. | 07/09/2026SE |
| K252984 | Perin Health System (PHD80060-2)DRG · Traditional | Perin Health Devices, LLC | 01/22/2026SE |
| K252440 | EasyTeleMed (2.0.2)DRG · Traditional | Ingeniars S.R.L. | 10/02/2025SE |
| K250259 | TeleRehab Aermos Cardiopulmonary RehabilitationDRG · Traditional | The ScottCare Corporation | 06/04/2025SE |
| K243837 | iBSMDRG · Traditional | Iorbit Digital Technologies Private Limited | 05/16/2025SE |
| K242018 | UbiqVue 2A Multi-parameter System (UX2550)DRG · Traditional | Lifesignals, Inc. | 11/12/2024SE |
| K241101 | BioButton SystemDRG · Traditional | Biointellisense, Inc. | 09/26/2024SE |
| K240251 | ANNE ChestDRG · Traditional | Sibel Health, Inc. | 06/03/2024SE |
| K220526 | HD+12, HD+15DRG · Traditional | Cardioline S.P.A | 05/15/2023SE |
| K223073 | AlioDRG · Traditional | Alio, Inc. | 03/17/2023SE |
More from Alio, Inc.
Questions and answers
When was ANNE One cleared by the FDA?
ANNE One (K223711) received a 510(k) decision of Substantially Equivalent on August 10, 2023, 241 days after the submission was received.
What is the product code of K223711?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.