510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DXRClass II

Ballistocardiograph

21 CFR 870.2320 / Cardiovascular
FDA source (opens on fda.gov)

DXR is the FDA product code for Ballistocardiograph, a class II device type, regulated under 21 CFR 870.2320. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DXR
Device name
Ballistocardiograph
Regulation
21 CFR 870.2320
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
0

Clearances, product code DXR

By decision year
5 clearances under product code DXR with a decision year between 1987 and 2025, 1987 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DXR by decision year
YearClearances
19872
20091
20161
20251

Applicants with the most clearances

Product code DXR
Applicants holding the most 510(k) clearances under product code DXR
ApplicantClearances
Cardiosense, Inc.1
Corsens Medical, Ltd.1
Frantz Medical Development, Ltd.1
Heartforce Medical, Inc.1
Vital Science Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code