Cleared Traditional

ANNE One

K223711 · Sibel Health, Inc. · Cardiovascular

Aug 2023

Decision

241d

Days

Class 2

Risk

About This 510(k) Submission

K223711 is an FDA 510(k) clearance for the ANNE One, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Sibel Health, Inc. (Niles, US). The FDA issued a Cleared decision on August 10, 2023, 241 days after receiving the submission on December 12, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K223711 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 2022
Decision Date	August 10, 2023
Days to Decision	241 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