Cleared Traditional

BodyGuardian Remote Monitoring System

K192732 · Preventice Technologies, Inc. · Cardiovascular

Mar 2020

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K192732 is an FDA 510(k) clearance for the BodyGuardian Remote Monitoring System, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Preventice Technologies, Inc. (Rochester, US). The FDA issued a Cleared decision on March 26, 2020, 181 days after receiving the submission on September 27, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number	K192732 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2019
Decision Date	March 26, 2020
Days to Decision	181 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF