FDA.reportPublic FDA data

510(k) K250634

Device
BCM2-Body Composition Monitor
Applicant
Fresenius Medical Care Renal Therapies Group, LLC
510(k) number
K250634
Product code
DSB
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-24
Date received
2025-03-03
Regulation
870.2770
Classification name
Plethysmograph, Impedance
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Christopher Doherty
Address
920 Winter St. Waltham MA US 02451 02451

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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