DeviceClearance

Product code DXH— Cardiovascular

AliveCor Heart Monitor

Classification name
Transmitters And Receivers, Electrocardiograph, Telephone
Device class
Class 2
Regulation
21 CFR 870.2920
Advisory panel
Cardiovascular
Total cleared
297
First cleared
Most recent

Market context for product code DXH

FDA has cleared 297 devices under product code DXH between 1976 and 2026, filed by 145 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

last 15 years

Top applicants under product code DXH

Recent clearances under product code DXH

1–100 of 297

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