Name: BodyGuardian Remote Monitoring System (BGRMS v3.0)
Brand: Boston Scientific Cardiac Diagnostic Technologies, Inc.
SKU: K243349

BodyGuardian Remote Monitoring System (BGRMS v3.0) is an FDA 510(k)-cleared medical device (K243349) manufactured by Boston Scientific Cardiac Diagnostic Technologies, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 22, 2026. Regulation: 8.

BodyGuardian Remote Monitoring System (BGRMS v3.0)

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