Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K112478 |
FOIA Releasable 510(k) |
K112478
|
Device Name |
VISI MOBILE MONITORING SYSTEM |
Applicant |
SOTERA WIRELESS, INC |
9444 WAPLES STREET |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
EBEN GORDON |
Correspondent |
SOTERA WIRELESS, INC |
9444 WAPLES STREET |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
EBEN GORDON |
Regulation Number | 870.2300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/29/2011 |
Decision Date | 03/22/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00881829
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|