Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K211232 |
Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant |
Aco Healthcare Co,. Ltd.
Rm. 520, Bldg. 53, No. 195, Sec. 4, Chungshin Rd., Chutung
Hsinchu 31057 TW
Other 510(k) Applications for this Company
|
Contact |
Henry Huang
Other 510(k) Applications for this Contact |
Regulation Number |
892.1550
More FDA Info for this Regulation Number |
Classification Product Code |
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
04/23/2021 |
Decision Date |
06/25/2021 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
RA - Radiology |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|