Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ANNE View, Central Hub

K-Number: K242842 · 2025-01-08

ApplicantSibel Health, Inc.
Decision Date2025-01-08
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANNE View, Central Hub is a medical device manufactured by Sibel Health, Inc.. It received FDA 510(k) clearance on 2025-01-08 under approval number K242842. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANNE View, Central Hub?

ANNE View, Central Hub is a medical device that received FDA 510(k) clearance on 2025-01-08. It is manufactured by Sibel Health, Inc.. The 510(k) number is K242842.

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

ANNE View, Central Hub received FDA 510(k) clearance on 2025-01-08, under approval number K242842.

What company makes ANNE View, Central Hub?

ANNE View, Central Hub is manufactured by Sibel Health, Inc..

What is the FDA product code for ANNE View, Central Hub?

The FDA product code for ANNE View, Central Hub is MSX.

Other Devices by Sibel Health, Inc.

K223711ANNE One K240251ANNE Chest K240305ANNE Limb K253021ANNE Maternal

Related Devices (Code: MSX)

K153156eCareManager 4.0.1Visicu, Inc. K160862AirStrip RPMAirstrip Technologies, Inc. K161164CareEvent inclusive of the CareEvent Mobile Application accessoryPhilips Medical Systems K171322eCareManager 4.1Visicu, Inc. K162607BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K180430Digistat Smart CentralAscom Ums Srl Unipersonale

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑