DeviceClearance

Product code DPS— Cardiovascular

DIGITAL ELECTROCARDIOGRAPH

Classification name
Electrocardiograph
Device class
Class 2
Regulation
21 CFR 870.2340
Advisory panel
Cardiovascular
Total cleared
576
First cleared
Most recent

Market context for product code DPS

FDA has cleared 576 devices under product code DPS between 1976 and 2026, filed by 272 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 DPS

Adverse events under product code DPS

product code DPS
Death
7
Total
7

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code DPS

1–100 of 576

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