Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K211098 |
Device Name |
Breast Volume Navigator (BVN) Model G-2000 |
Applicant |
MetriTrack, Inc. |
4415 W. Harrison Street |
Suite 243 |
Hillside,
IL
60162
|
|
Applicant Contact |
Mirela Wohlford |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/13/2021 |
Decision Date | 05/26/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|