Cleared Traditional

ANNE View, Central Hub

K242842 · Sibel Health, Inc. · Cardiovascular

Jan 2025

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K242842 is an FDA 510(k) clearance for the ANNE View, Central Hub, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Sibel Health, Inc. (Chicago, US). The FDA issued a Cleared decision on January 8, 2025, 111 days after receiving the submission on September 19, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K242842 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 19, 2024
Decision Date	January 08, 2025
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF