DeviceClearance

Product code JOM— Cardiovascular

3D VASCULAR RECORDER

Classification name
Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Device class
Class 2
Regulation
21 CFR 870.2780
Advisory panel
Cardiovascular
Total cleared
53
First cleared
Most recent

Market context for product code JOM

FDA has cleared 53 devices under product code JOM between 1976 and 2022, filed by 40 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 JOM

Recent clearances under product code JOM

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