Devices · Boston Scientific Cardiac Diagnostic Technologies, Inc.
BodyGuardian Remote Monitoring System (BGRMS v3.0)
Boston Scientific Cardiac Diagnostic Technologies, Inc. is listed for BodyGuardian Remote Monitoring System (BGRMS v3.0) (K243349). The FDA list gives January 23, 2026 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is DSI. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K243349
- Date of final decision
- January 23, 2026
- Company on the FDA list
- Boston Scientific Cardiac Diagnostic Technologies, Inc.
- Lead panel
- Cardiovascular
- Primary product code
- DSI
- openFDA device name for the code
- Detector And Alarm, Arrhythmia
- Device class
- 2
- Regulation number
- 870.1025
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary