Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K140339 |
Device Name |
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM |
Applicant |
COVIDIEN |
6135 GUNBARREL AVE. |
BOULDER,
CO
80301
|
|
Applicant Contact |
BRIANNA REYNOLDS |
Correspondent |
COVIDIEN |
6135 GUNBARREL AVE. |
BOULDER,
CO
80301
|
|
Correspondent Contact |
BRIANNA REYNOLDS |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 02/10/2014 |
Decision Date | 04/10/2014 |
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
|
|
|