Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K220800 |
Device Name |
Venue Go |
Applicant |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
LLC |
9900 W. Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
Lee Bush |
Correspondent |
GE Medical Systems Ultrasound and Primary Care Diagnostics |
LLC |
9900 W. Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
Lee Bush |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/18/2022 |
Decision Date | 06/21/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|