Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015529350

FEI Number

3015529350

Entity Name

SIBEL HEALTH INC.

City/State/Country

Chicago, IL, US

Establishment Address

2017 N Mendell Street, Suite 2SE, Chicago, IL 60614, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sibel Health Inc. (Owner Number: 10060887)

Owner / Operator Contact Address

2017 N Mendell St, Suite 2SE, Chicago, IL 60614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240251

PMA Number

N/A

All Registered Proprietary Names

ANNE Maternal Software Platform ANNE Maternal ANNE Sleep ANNE One ANNE Chest

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2026-03-18
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2026-03-18
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2026-03-18
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2026-03-18
MSW	System, Test, Thyroglobulin	Immunology	Class 2	866.6010	2026-03-18
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2026-03-18
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2025-01-20
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2025-01-20
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2025-01-20
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2025-01-20
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2022-07-18
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-08-14
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2023-08-14
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2023-08-14
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2023-08-14
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-08-14
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-08-14
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2024-07-31
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-07-31
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2024-07-31
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2024-07-31
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2024-07-31
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-07-31

Official Correspondent

Kevin Dwyer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sibel Health Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K771196	Hewlett-Packard Co.	MARKER GENERATOR MODULES - 21597A	1977-08-03
K813458	Cranbury Medical Labs, Inc.	FETASCAN 1000, 1000A OBSTETRICAL DATA	1982-01-28
K100420	Philips Medizin Systeme Boeblingen GmbH	PHILIPS OBTRACEVUE MODEL SW REV. G.00	2010-07-26
K173941	Philips Medizin Systeme Boeblingen GmbH	IntelliSpace Perinatal Rev.K.00	2018-09-10
K062137	Philips Medizin Systeme Boeblingen GmbH	MODIFICATION TO PHILIPS AVALON FETAL MONITORS FM20 AND FM30	2006-08-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-06	N/A	2	FETALGARD Lite Fetal Monitors, Model AP1S (Single Fetus Monitoring)
Z-0036-06	N/A	2	FETALGARD Lite Fetal Monitors, Model HCS (Home Care Single Fetus Monitoring)
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.

Similar Registrations

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3007734888	WIPRO GE HEALTHCARE PRIVATE Ltd.	BANGALORE Karnataka, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015529350. Last updated year: 2026. Please use registration number 3015529350 when referencing this establishment in official correspondence.