Device Classification Name |
System, Measurement, Blood-Pressure, Non-Invasive
|
510(k) Number |
K163255 |
Device Name |
CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor |
Applicant |
Caretaker Medical, LLC |
3042 Berkmar Drive, Suite A |
Charlottesville,
VA
22901
|
|
Applicant Contact |
Jeff Pompeo |
Correspondent |
Caretaker Medical, LLC |
3042 Berkmar Drive, Suite A |
Charlottesville,
VA
22901
|
|
Correspondent Contact |
Jeff Pompeo |
Regulation Number | 870.1130
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/21/2016 |
Decision Date | 04/21/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|