Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K161517 |
Device Name |
Mortara Surveyor Patient Monitor |
Applicant |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH STREET |
MILWAUKEE,
WI
53224
|
|
Applicant Contact |
SARAH WEBER |
Correspondent |
MORTARA INSTRUMENT, INC. |
7865 NORTH 86TH STREET |
MILWAUKEE,
WI
53224
|
|
Correspondent Contact |
SARAH WEBER |
Regulation Number | 870.1025
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/02/2016 |
Decision Date | 01/11/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02642198
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|