Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 a medical device manufactured by Preventice Technologies, Inc.. It received FDA 510(k) clearance on 2020-03-26 under approval 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. It is manufactured by Preventice Technologies, Inc.. The 510(k) number is K192732.

When was BodyGuardian Remote Monitoring System approved by the FDA?

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

What company makes BodyGuardian Remote Monitoring System?

BodyGuardian Remote Monitoring System is manufactured by Preventice Technologies, Inc..

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

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

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT06682013 Virtual Agent Feasibility in Oncology Patients (NTT Data) WITHDRAWN NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING

Related PubMed Literature

PMID: 40947420 Software as Medical Devices: requirements and regulatory landscape in the United States. Expert review of medical devices (2025) PMID: 39396094 A scoping review on advancements in noninvasive wearable technology for heart failure management. NPJ digital medicine (2024) PMID: 37948287 TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability. Military medicine (2023) PMID: 37459057 Assessment of US Food and Drug Administration-Approved Digital Medical Devices for Just-in-Time Interventions: A Systematic Review. JAMA internal medicine (2023)

Related Devices (Code: DSI)

K153473Braemar Telemetry Patch SystemBraemar Manufacturing, LLC K153477EMMa Electronic Monitoring ManagementVitasystems GmbH K152701Matrix Mini ECG MonitorGlobal Instrumentation, LLC K152305Nihon Kohden Afib Detection Program QP-039PNihon Kohden Corporation K151835Vital Signs Patch SystemLifewatch Technologies , Ltd. K151269ECG Mini System Continuous ECG Monitor and Arrhythmia DetectorLifewatch Technologies , Ltd.

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.

↑