DeviceClearance

Product code MWJ— Cardiovascular

Biotres

Classification name
Electrocardiograph, Ambulatory (Without Analysis)
Device class
Class 2
Regulation
21 CFR 870.2800
Advisory panel
Cardiovascular
Total cleared
62
First cleared
Most recent

Market context for product code MWJ

FDA has cleared 62 devices under product code MWJ between 1998 and 2026, filed by 44 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 MWJ

Adverse events under product code MWJ

product code MWJ
Other
1
Total
1

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 MWJ

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