Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K213689 |
Device Name |
Voluson P6, Voluson P8 |
Applicant |
GE Healthcare |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Applicant Contact |
Bryan Behn |
Correspondent |
GE Healthcare |
9900 Innovation Drive |
Wauwatosa,
WI
53226
|
|
Correspondent Contact |
Bryan Behn |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/23/2021 |
Decision Date | 02/17/2022 |
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
|
|
|