Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K151910 |
Device Name |
Ultrasound Scanner System BK2300 |
Applicant |
BK MEDICAL APS |
MILEPARKEN 34 |
HERLEV,
DK
DK-2730
|
|
Applicant Contact |
Randi Hauerberg |
Correspondent |
BK MEDICAL APS |
MILEPARKEN 34 |
HERLEV,
DK
DK-2730
|
|
Correspondent Contact |
Randi Hauerberg |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/13/2015 |
Decision Date | 10/05/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|