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SIBEL HEALTH INC.

Matched from indexed company URL: Sibel, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30155293503015529350SIBEL HEALTH INC.1N2026-01-012017 N Mendell Street Suite 2SE Chicago IL US 60614

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2315111826121352K253021ANNE MaternalHGM2026-02-26
2315112004838586K242842ANNE View, Central HubMSX2025-01-08
2315111633607986K240305ANNE LimbDQA2024-05-28
2315111934524595K240251ANNE ChestDRG2024-06-03
2315111076529511K223711ANNE OneDRG2023-08-10
2315111345417416K221530ANNE PediatricDRG2022-11-22
2315111403969123K220095ANNE SleepMNR2022-07-11
2315111330911204K211305ANNE OneDRG2021-09-14
2315111520906592
2315111168046939

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DRG42024-06-03
HGM12026-02-26
MSX12025-01-08
DQA12024-05-28
MNR12022-07-11

PMN#

GUDID#

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.

Sibel Health Inc.

2021-10-20