BLADDERSCAN BVI 6100


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K022153
Device Name BLADDERSCAN BVI 6100
Original Applicant
DIAGNOSTIC ULTRASOUND CORP.
21222 30th drive se, ste. 120
bothell, 
WA 
98021

Original Contact russ garrison
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received 07/02/2002
Decision Date 08/15/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No