DXR

Ballistocardiograph

Product code
DXR
Device name
Ballistocardiograph
Device class
Class 2
21 CFR
21 CFR 870.2320
Medical specialty
Cardiovascular
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
5 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-07-22.

NumberDecision dateApplicantDevice nameSummary
K2435662025-07-22Cardiosense, Inc.CardioTag™PDF

1 summaries are archived here for direct download.

Official FDA classification page: DXR
Classification and pathway per current FDA publications. Data from openFDA (CC0).