Product code FMJ— General Hospital

BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETER

Classification name
Manometer, Spinal-Fluid
Device class
Class 2
Regulation
21 CFR 880.2500
Advisory panel
General Hospital
Total cleared
6
First cleared
Most recent

Market context for product code FMJ

FDA has cleared 6 devices under product code FMJ between 1988 and 2017, filed by 6 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 FMJ

Recent clearances under product code FMJ

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