Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K133277 |
Device Name |
XARIO 100 |
Applicant |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
2441 MICHELLE DRIVE |
TUSTIN,
CA
92780
|
|
Applicant Contact |
CHARLEMAGNE CHUA |
Correspondent |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
2441 MICHELLE DRIVE |
TUSTIN,
CA
92780
|
|
Correspondent Contact |
CHARLEMAGNE CHUA |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/24/2013 |
Decision Date | 01/17/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|