FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BodyGuardian Remote Monitoring System (BGRMS v3.0)
K Number: K243349
·
Decision Jan 23, 2026
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
1
Review Days
452
Basic Information
- Device Name
- BodyGuardian Remote Monitoring System (BGRMS v3.0)
- K Number
- K243349
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Cardiac Diagnostic Technologies, Inc.
- Date Received
- October 28, 2024
- Decision Date
- January 23, 2026
- Product Code
- DSI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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