Product code CAR— General Hospital

BION MUMPS-G ANTIBODY TEST SYSTEM

Classification name
Monitor, Spinal-Fluid Pressure, Electrically Powered
Device class
Class 2
Regulation
21 CFR 880.2460
Advisory panel
General Hospital
Total cleared
3
First cleared
Most recent

Market context for product code CAR

FDA has cleared 3 devices under product code CAR between 1992 and 1994, filed by 3 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

Top applicants under product code CAR

Recent clearances under product code CAR

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