Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K022153 |
Device Name |
BLADDERSCAN BVI 6100 |
Applicant |
DIAGNOSTIC ULTRASOUND CORP. |
21222 30TH DRIVE SE, STE. 120 |
BOTHELL,
WA
98021
|
|
Applicant Contact |
RUSS GARRISON |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
|
|