BCM2-Body Composition Monitor— 510(k) K250634
Substantially EquivalentFresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) clearance K250634 for BCM2-Body Composition Monitor, Substantially Equivalent on 2025-11-24. Applicant: Fresenius Medical Care Renal Therapies Group, LLC. Device class: 2.
Clearance details
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Product code
- Code DSB
- Device class
- Class 2
- Regulation
- 21 CFR 870.2770
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waltham, MA, US
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