ANNE View, Central Hub

FDA 510(k) K242842 · Sibel Health, Inc.

Substantially Equivalent

510(k) numberK242842

Submission

Device name
ANNE View, Central Hub
Applicant
Sibel Health, Inc.
Chicago, IL, US
Received
September 19, 2024
Decision date
January 8, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MSX – System, Network And Communication, Physiological Monitors
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2300
Specialty
Cardiovascular
Life-sustaining
Yes

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K253654IntelliVue Measurement Rack 6000 (867317)MSX · Traditional Philips Medizin Systeme Böblingen GmbH03/30/2026SE
K243270TigerConnect Alarm ManagementMSX · Traditional Tigerconnect09/30/2025SE
K242728BeneVision Central Monitoring SystemMSX · Traditional Shenzhen Mindray Bio-Medical Electronics Co., Ltd.07/31/2025SE
K242750Central StationMSX · Traditional Nihon Kohden Digital Health Solutions, LLC06/05/2025SE
K241397HinscopeMSX · Traditional Hinlab Sas11/14/2024SE
K233834Infinity Gateway SuiteMSX · Traditional Draeger Medical Systems, Inc.07/12/2024SE
K233418Biofourmis Everion+ (G2)MSX · Traditional Biofourmis Singapore Pte., Ltd.05/09/2024SE

More from Biofourmis Singapore Pte., Ltd.

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Questions and answers

When was ANNE View, Central Hub cleared by the FDA?

ANNE View, Central Hub (K242842) received a 510(k) decision of Substantially Equivalent on January 8, 2025, 111 days after the submission was received.

What is the product code of K242842?

The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.