Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K211232 |
Device Name |
Apache Ultrasound System |
Applicant |
Aco Healthcare Co,. Ltd. |
Rm. 520, Bldg. 53, No. 195, Sec. 4, Chungshin Rd., Chutung |
Hsinchu,
TW
31057
|
|
Applicant Contact |
Henry Huang |
Correspondent |
Aco Healthcare Co,. Ltd. |
Rm. 520, Bldg. 53, No. 195, Sec. 4, Chungshin Rd., Chutung |
Hsinchu,
TW
31057
|
|
Correspondent Contact |
Henry Huang |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 04/23/2021 |
Decision Date | 06/25/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|