Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K201633 |
Device Name |
Terason uSmart 3200T Plus Ultrasound System |
Applicant |
Teratech Corporation |
77-79 Terrace Hall Ave. |
burlington,
MA
01803
|
|
Applicant Contact |
benjamin chiampa |
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 | 06/16/2020 |
Decision Date | 07/02/2020 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|