Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K203657 |
Device Name |
Vu-Path Ultrasound System |
Applicant |
Crystalline Medical |
48890 Milmont Drive |
Suite 106D |
Fremont,
CA
94538
|
|
Applicant Contact |
Ivan Ma |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
Prithul Bom |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/15/2020 |
Decision Date | 06/25/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|