Device Classification Name |
System, Imaging, Pulsed Doppler, Ultrasonic
|
510(k) Number |
K231764 |
Device Name |
Ultrasound System 1300 |
Applicant |
BK Medical Aps |
Mileparken 34 |
Herlev,
DK
2730
|
|
Applicant Contact |
Bryan Behn |
Correspondent |
BK Medical Aps |
Mileparken 34 |
Herlev,
DK
2730
|
|
Correspondent Contact |
Bryan Behn |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/16/2023 |
Decision Date | 10/23/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|