Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K202119 |
Device Name |
AcuSee AS-P1000 System |
Applicant |
Weipeng (Suzhou) Medical Devices Co., Ltd. |
Unit 207, Building B2, Biobay, 218 Xinghu St., |
Suzhou Industrial Park |
Suzhou,
CN
215123
|
|
Applicant Contact |
Bin Yang |
Correspondent |
Springborne Life Sciences |
750 Menlo Avenue, Suite 200 |
Menlo Park,
CA
94025
|
|
Correspondent Contact |
Geetha Rao |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 07/30/2020 |
Decision Date | 10/07/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|