DeviceClearance

Product code DXR— Cardiovascular

CardioTag

Classification name
Ballistocardiograph
Device class
Class 2
Regulation
21 CFR 870.2320
Advisory panel
Cardiovascular
Total cleared
5
First cleared
Most recent

Market context for product code DXR

FDA has cleared 5 devices under product code DXR between 1987 and 2025, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code DXR

Recent clearances under product code DXR

Data sourced from openFDA. This site is unofficial and independent of the FDA.