Cleared Traditional

BioSticker System

K191614 · Biointellisense, Inc. · Cardiovascular

Dec 2019

Decision

183d

Days

Class 2

Risk

About This 510(k) Submission

K191614 is an FDA 510(k) clearance for the BioSticker 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 December 18, 2019, 183 days after receiving the submission on June 18, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2910.

Submission Details

510(k) Number	K191614 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2019
Decision Date	December 18, 2019
Days to Decision	183 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Statement

Device Classification

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