Cleared Traditional

BioButton System

K241101 · Biointellisense, Inc. · Cardiovascular

Sep 2024

Decision

157d

Days

Class 2

Risk

About This 510(k) Submission

K241101 is an FDA 510(k) clearance for the BioButton System, a Transmitters And Receivers, Physiological Signal, Radiofrequency (Class II — Special Controls, product code DRG), submitted by Biointellisense, Inc. (Redwood City, US). The FDA issued a Cleared decision on September 26, 2024, 157 days after receiving the submission on April 22, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K241101 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 2024
Decision Date	September 26, 2024
Days to Decision	157 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