Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K050363 |
Device Name |
FUKUDA DENSHI MODEL UF-850XTD |
Applicant |
FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C |
REDMOND,
WA
98052 -4911
|
|
Applicant Contact |
LARRY D WALKER |
Correspondent |
FUKUDA DENSHI USA, INC. |
17725 N.E. 65TH ST., BLDG. C |
REDMOND,
WA
98052 -4911
|
|
Correspondent Contact |
LARRY D WALKER |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/14/2005 |
Decision Date | 02/17/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|