Device Classification Name |
system, measurement, blood-pressure, non-invasive
|
510(k) Number |
K211588 |
Device Name |
Caretaker Platform, VitalStream Platform, CT5 |
Applicant |
Caretaker Medical |
941 Glenwood Station Ln #301 |
Charlottesville,
VA
22901
|
|
Applicant Contact |
Jeff Pompeo |
Correspondent |
Caretaker Medical |
941 Glenwood Station Ln #301 |
Charlottesville,
VA
22901
|
|
Correspondent Contact |
Jeff Pompeo |
Regulation Number | 870.1130
|
Classification Product Code |
|
Date Received | 05/24/2021 |
Decision Date | 08/13/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|