Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BodyGuardian Remote Monitoring System

K-Number: K192732 · 2020-03-26

ApplicantPreventice Technologies, Inc.
Decision Date2020-03-26
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BodyGuardian Remote Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Preventice Technologies, Inc.. It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K192732. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BodyGuardian Remote Monitoring System?

BodyGuardian Remote Monitoring System is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Preventice Technologies, Inc.. The 510(k) number is K192732.

When did BodyGuardian Remote Monitoring System receive FDA 510(k) clearance?

BodyGuardian Remote Monitoring System received FDA 510(k) clearance on 2020-03-26, under 510(k) number K192732.

Who is the listed applicant for BodyGuardian Remote Monitoring System?

The FDA 510(k) record lists Preventice Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BodyGuardian Remote Monitoring System?

The FDA product code for BodyGuardian Remote Monitoring System is DSI.

Related Devices (Code: DSI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑