DeviceClearance

Product code JWO— Hematology

Blood Volume Analyzer (200)

Classification name
Device, Blood Volume Measuring
Device class
Class 2
Regulation
21 CFR 864.5950
Advisory panel
Hematology
Total cleared
3
First cleared
Most recent

Market context for product code JWO

FDA has cleared 3 devices under product code JWO between 1997 and 2026, filed by 1 applicant company. 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 JWO

Recent clearances under product code JWO

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