Sibel Inc.

Address:6650 W Touhy Ave,Niles,IL,60714,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (1) Thermometer, Electronic, Clinical (FLL) (1) Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG) (1) Ventilatory Effort Recorder (MNR) (1)

Premarket Exempt

Clear

ANNE™ One - 00860004541707 Catalog Number :

Device Description : ANNE One is a wireless vital signs and physiological data monitoring platform th 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.

Device Class : 2

Duns Number: 093772547

Premarket Exempt : No

Product Code : DRG, MWI, FLL

Prescription Use : Yes

Device Count : 1

ANNE Sleep - 00860004541714 Catalog Number :

Device Description : ANNE Sleep is a wearable sensor system intended for use in the collection, analy 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.

Device Class : 2

Duns Number: 093772547

Premarket Exempt : No

Product Code : MNR

Prescription Use : Yes

Device Count : 1

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