Device Classification Name |
computer, diagnostic, programmable
|
510(k) Number |
K202094 |
Device Name |
Cardiovascular Suite 4.2.1 |
Applicant |
Quipu S.R.L |
Moruzzi 1 56124 |
Pisa,
IT
56124
|
|
Applicant Contact |
Vincenzo Gemignani |
Correspondent |
Thomas Regulatory Resolutions, Inc. |
5613 Tiger Way |
Winter Garden,
FL
34787
|
|
Correspondent Contact |
Dallas L. Thomas |
Regulation Number | 870.1425
|
Classification Product Code |
|
Date Received | 07/28/2020 |
Decision Date | 01/11/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|