Device Classification Name |
System, Imaging, Pulsed Echo, Ultrasonic
|
510(k) Number |
K171309 |
Device Name |
BR-FHUS Navigation 1.0 |
Applicant |
TaiHao Medical Inc. |
3F.-8, No.100, Sec. 2 |
Heping E. Rd., Da'am Dist. |
Taipei,
TW
10663
|
|
Applicant Contact |
Hsin Hung Lai |
Correspondent |
Lin & Associates, LLC |
5614 Johnson Avenue |
Bethesda,
MD
20817
|
|
Correspondent Contact |
Chiu S. Lin |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 05/03/2017 |
Decision Date | 09/29/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|