Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device |
510(K) Number |
K212100 |
Device Name |
System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant |
EchoNous, Inc.
8310 154th Ave NE, Building B, Suite 200
Redmond, WA 98052 US
Other 510(k) Applications for this Company
|
Contact |
Carly Hom
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 |
07/06/2021 |
Decision Date |
08/06/2021 |
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 |
Y |
Expedited Review |
|