MODEL AMI1200 C-ARM


Device Classification Name

system, x-ray, fluoroscopic, image-intensified

510(k) Number K022911
Device Name MODEL AMI1200 C-ARM
Original Applicant
INTEGRITY PRACTICE MANAGEMENT, INC.
1104 enterprise dr.
sioux falls, 
SD 
57106

Original Contact kevin j meuret
Regulation Number 892.1650
Classification Product Code
JAA  
Date Received 09/03/2002
Decision Date 12/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No