Device Classification Name |
system, imaging, pulsed doppler, ultrasonic
|
510(k) Number |
K163082 |
Device Name |
6200 Ultrasound System and 6250 Ultrasound System |
Applicant |
ESAOTE S.P.A |
VIA A. SIFFREDI 58 |
GENOVA,
IT
16153
|
|
Applicant Contact |
MASSIMO POLIGNANO |
Correspondent |
NAVIGANT CONSULTING, INC. |
9001 WESLEYAN ROAD, SUITE 200 |
INDIANAPOLIS,
IN
46268
|
|
Correspondent Contact |
ALLISON SCOTT |
Regulation Number | 892.1550
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 11/03/2016 |
Decision Date | 03/16/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|