ANNE View, Central Hub
Sibel Health, Inc.
SIBEL HEALTH INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015529350 | 3015529350 | SIBEL HEALTH INC. | 1 | N | 2026-01-01 | 2017 N Mendell Street Suite 2SE Chicago IL US 60614 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 231511 | 1826121352 | K253021 | ANNE Maternal | HGM | 2026-02-26 |
| 231511 | 2004838586 | K242842 | ANNE View, Central Hub | MSX | 2025-01-08 |
| 231511 | 1633607986 | K240305 | ANNE Limb | DQA | 2024-05-28 |
| 231511 | 1934524595 | K240251 | ANNE Chest | DRG | 2024-06-03 |
| 231511 | 1076529511 | K223711 | ANNE One | DRG | 2023-08-10 |
| 231511 | 1345417416 | K221530 | ANNE Pediatric | DRG | 2022-11-22 |
| 231511 | 1403969123 | K220095 | ANNE Sleep | MNR | 2022-07-11 |
| 231511 | 1330911204 | K211305 | ANNE One | DRG | 2021-09-14 |
| 231511 | 1520906592 | ||||
| 231511 | 1168046939 |
Product Codes Associated With Registrations#
PMN#
ANNE Chest
Sibel Health, Inc.
ANNE Limb
Sibel Health, Inc.
ANNE One
Sibel Health, Inc.
ANNE Pediatric
Sibel, Inc.
ANNE Sleep
Sibel Inc.
ANNE One
Sibel Inc.
GUDID#
ANNE Chest Adhesive - Gentle Wear Shelf Box - 900-00072
2025-12-17
ANNE Link Mobile - 900-00069
2025-12-11
ANNE Limb - ANNE Limb is a pulse oximeter intended for continuous monitoring of SpO2, pulse rate, and skin temperature.
2025-04-02
ANNE Chest - The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
2025-04-02
Sibel Spacelabs Trek Tablet - 900-00043
2025-04-02
Sibel Spacelabs Trek Blood Pressure Cuff - 900-00045
2025-04-02
Sibel Spacelabs Trek Chest Patch Adhesive - 900-00062
2025-04-02
Sibel Spacelabs Finger Patch Adhesive 3 day - 900-00042
2025-04-02
Sibel Spacelabs Trek Charger - 900-00046
2025-04-02
Sibel Spacelabs Trek Finger Patch - 900-00041
2025-04-02
Sibel Spacelabs Trek Chest Patch - 900-00039
2025-04-02
Central Hub Speaker - 900-00004
2025-03-27
Central Hub CMS - 900-00013
2025-03-27
ANNE Limb Adhesive Shelf Box - Box of 50 ANNE Limb Adhesives
2025-03-27
ANNE Limb Sensor - 810-00013
2025-03-26
ANNE Chest Sensor - 810-00012
2025-03-26
ANNE View Patient Monitor - Patient monitor consisting of a mobile tablet and the ANNE View software. The ANNE View Patient Monitor connects to the ANNE Chest sensor, ANNE Limb sensor, and compatible devices for the real-time display of physiological data.
2025-03-26
7-Day ANNE Chest Adhesive Shelf Box - Box of 30 7-Day adhesives for the ANNE Chest sensor.
2025-03-26
ANNE Limb Sensor Kit - ANNE Limb is a pulse oximeter intended for continuous monitoring of SpO2, pulse rate, and skin temperature.
2025-03-26
ANNE Bedside Wireless Charger - Bedside charger for the ANNE Chest and ANNE Limb sensors.
2025-03-26
1-Day ANNE Chest Adhesive Pouch - Pouch of 10 1-Day adhesives for the ANNE Chest sensor.
2025-03-26
7-Day ANNE Chest Adhesive Pouch - Pouch of 5 7-Day Adhesives for the ANNE Chest sensor.
2025-03-26
ANNE Chest Sensor Kit - The ANNE Chest is a wearable, wireless sensor intended for the measurement of ECG waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature.
2025-03-26
ANNE™ One - ANNE One is a wireless vital signs and physiological data monitoring platform that streams real-time biosignals including electrocardiography, acceleration, and temperature to measure vital signs such as heart rate, respiratory rate, body temperature, skin temperature, step count, and fall count. The system features two skin-mounted, bio-integrated sensors that pair with an associated proprietary software application for the display of real-time vital sign measurements.
2021-10-20
ANNE Sleep - ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the diagnosis of sleep-related breathing disorders by healthcare professionals.
2022-07-20
ANNE Pediatric - ANNE Pediatric is a wireless vital signs monitoring platform for use on neonatal patients of any gestational age up to infants 2 years of age.
2022-12-22