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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 a medical device manufactured by Boston Scientific Cardiac Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 2026-01-23 under approval 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. It is manufactured by Boston Scientific Cardiac Diagnostic Technologies, Inc.. The 510(k) number is K243349.

When was BodyGuardian Remote Monitoring System (BGRMS v3.0) approved by the FDA?

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

What company makes BodyGuardian Remote Monitoring System (BGRMS v3.0)?

BodyGuardian Remote Monitoring System (BGRMS v3.0) is manufactured by Boston Scientific Cardiac Diagnostic Technologies, Inc..

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.

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Related PubMed Literature

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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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