Cleared Traditional

ANNE Chest

K240251 · Sibel Health, Inc. · Cardiovascular

Jun 2024

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K240251 is an FDA 510(k) clearance for the ANNE Chest, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Sibel Health, Inc. (Chicago, US). The FDA issued a Cleared decision on June 3, 2024, 125 days after receiving the submission on January 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K240251 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 2024
Decision Date	June 03, 2024
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2910