HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F


Device Classification Name

interventional fluoroscopic x-ray system

510(k) Number K081073
Device Name HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
Applicant
PAUSCH LLC
808 shrewsbury avenue
tinton falls, 
NJ 
07724 -3002

Applicant Contact justin tice
Correspondent
PAUSCH LLC
808 shrewsbury avenue
tinton falls, 
NJ 
07724 -3002

Correspodent Contact justin tice
Regulation Number 892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   MQB  
Date Received 04/15/2008
Decision Date 12/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No