Data / Medical devices / United States / Sibel Health Inc.
Sibel Health Inc.: FDA-registered device maker in Chicago, IL, United States, 8 510(k) clearances
Sibel Health Inc. is registered with the FDA (registration 3015529350) in Chicago, IL, United States. It lists 13 device types. The FDA files 8 510(k) clearances under its listings, the newest dated February 26, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015529350
- Address
- 2017 N Mendell Street Suite 2SE, Chicago, IL, United States, 60614
- Owner or operator
- Sibel Health Inc. (10060887)
- Roles
- Manufacturer
- First device listed
- September 15, 2021
- Registered through
- 2027
- Brand names listed
- ANNE Chest, ANNE Limb, ANNE Maternal, ANNE Maternal Software Platform, ANNE One, ANNE Pediatric, ANNE Sleep
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alarm, Blood-Pressure | DSJ | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory (Without Analysis) | MWJ | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Bed Patient | KMI | 1 | Manufacturer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Manufacturer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Manufacturer | accessdata.fda.gov |
| System, Monitoring, Perinatal | HGM | 2 | Manufacturer | accessdata.fda.gov |
| System, Network And Communication, Physiological Monitors | MSX | 2 | Manufacturer | accessdata.fda.gov |
| System, Test, Thyroglobulin | MSW | 2 | Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 26, 2026 | K253021 | ANNE Maternal | HGM | Substantially Equivalent | Sibel Health, Inc. | accessdata.fda.gov |
| January 8, 2025 | K242842 | ANNE View, Central Hub | MSX | Substantially Equivalent | Sibel Health, Inc. | accessdata.fda.gov |
| June 3, 2024 | K240251 | ANNE Chest | DRG | Substantially Equivalent | Sibel Health, Inc. | accessdata.fda.gov |
| May 28, 2024 | K240305 | ANNE Limb | DQA | Substantially Equivalent | Sibel Health, Inc. | accessdata.fda.gov |
| August 10, 2023 | K223711 | ANNE One | DRG | Substantially Equivalent | Sibel Health, Inc. | accessdata.fda.gov |
| November 22, 2022 | K221530 | ANNE Pediatric | DRG | Substantially Equivalent | Sibel, Inc. | accessdata.fda.gov |
| July 11, 2022 | K220095 | ANNE Sleep | MNR | Substantially Equivalent | Sibel, Inc. | accessdata.fda.gov |
| September 14, 2021 | K211305 | ANNE One | DRG | Substantially Equivalent | Sibel, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Continuous Measurement Thermometer
- All makers of Medical Device Data System
- All makers of Monitor, Bed Patient
- All makers of Monitor, Breathing Frequency
Updated February 26, 2026. 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.