Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K014116 |
Device Name |
HAND-CARRIED ULTRASOUND SYSTEM |
Applicant |
SONOSITE,INC. |
21919 30TH DRIVE SE. |
BOTHELL,
WA
98021 -3904
|
|
Applicant Contact |
MICHAEL HOFFMAN |
Correspondent |
TUV PRODUCT SERVICE, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1550
|
Classification Product Code |
|
Date Received | 12/14/2001 |
Decision Date | 12/20/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|