Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K160685 |
Device Name |
Surveyor S4 Mobile 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 | 03/11/2016 |
Decision Date | 08/04/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|