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FDA 510(k)

BodyGuardian Remote Monitoring System (BGRMS v3.0)

K-Number: K243349 · 2026-01-23

ApplicantBoston Scientific Cardiac Diagnostic Technologies, Inc.
Decision Date2026-01-23
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BodyGuardian Remote Monitoring System (BGRMS v3.0) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Cardiac Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 2026-01-23 under 510(k) number K243349. 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 (BGRMS v3.0)?

BodyGuardian Remote Monitoring System (BGRMS v3.0) is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Boston Scientific Cardiac Diagnostic Technologies, Inc.. The 510(k) number is K243349.

When did BodyGuardian Remote Monitoring System (BGRMS v3.0) receive FDA 510(k) clearance?

BodyGuardian Remote Monitoring System (BGRMS v3.0) received FDA 510(k) clearance on 2026-01-23, under 510(k) number K243349.

Who is the listed applicant for BodyGuardian Remote Monitoring System (BGRMS v3.0)?

The FDA 510(k) record lists Boston Scientific Cardiac Diagnostic 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 (BGRMS v3.0)?

The FDA product code for BodyGuardian Remote Monitoring System (BGRMS v3.0) 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.

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.K192732BodyGuardian Remote Monitoring SystemPreventice Technologies, Inc.

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.

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