← Back to catalogue

ANNE View Central Hub

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K242842

by Sibel Health Inc.

Identifiers

510(k) Number
K242842 FDA 510(k)
FDA Product Code
MSX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ANNE View Central Hub is a System, Network and Communication Device designed for physiological monitoring. It serves as a central interface to aggregate, process, and transmit data from multiple connected patient monitors, enabling real-time clinical decision support and seamless integration with hospital information systems.

This device is intended for use in clinical settings such as hospitals and cardiac care units, where it facilitates the consolidation of monitoring data from various sources. Supplied as a reusable, non-sterile Class II medical device, it adheres to FDA 510(k) and MDR regulatory standards. The Central Hub operates within standard electromagnetic environments and does not require special storage conditions, though proper handling and calibration are recommended for optimal performance.

Frequently asked questions

What clinical environments is the ANNE View Central Hub designed to support, and how does it integrate with existing systems?

The ANNE View Central Hub is specifically designed for use in clinical settings like hospitals and cardiac care units. It acts as a central interface to aggregate, process, and transmit physiological monitoring data from multiple connected patient monitors in real-time. This enables seamless integration with hospital information systems, facilitating consolidated data access for clinical decision support.

Is the ANNE View Central Hub reusable or single-use, and what sterility status does it have?

The ANNE View Central Hub is supplied as a reusable, non-sterile Class II medical device. Since it functions as a network and communication system rather than a direct patient interface, sterility is not a requirement for its operation.

What regulatory pathways has the ANNE View Central Hub followed, and what does this mean for its use?

The ANNE View Central Hub has undergone FDA 510(k) clearance and adheres to MDR (Medical Device Regulation) standards. This means it has been evaluated for substantial equivalence to a predicate device and meets EU regulatory requirements, ensuring compliance with both U.S. and European medical device regulations.

Does the ANNE View Central Hub require any special storage conditions, and what maintenance is recommended?

The device does not require special storage conditions like temperature control or humidity regulation. However, proper handling and periodic calibration are recommended to ensure optimal performance, as outlined in the manufacturer’s guidelines.

What types of patient monitors can connect to the ANNE View Central Hub, and how does it support cardiovascular monitoring?

The ANNE View Central Hub is designed to integrate with a variety of physiological monitors, as indicated by its OpenFDA registration numbers under the category *System, Network and Communication, Physiological Monitors*. While it consolidates data from multiple sources, its primary application is in cardiovascular-focused settings, supporting real-time monitoring and decision-making in cardiac care units.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sibel Health Inc.
FDA Applicant
Sibel Health, Inc.

Sources (2)

  • FDA 510(k) K242842 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 19, 2026