IMPERIUM


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K022114
Device Name IMPERIUM
Original Applicant
ELMSTECH, INC.
950 jericho turnpike
westbury, 
NY 
11590

Original Contact tim mangeruga
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received 06/28/2002
Decision Date 09/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No