Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K121424 |
Device Name |
EXPRESSION INFORMATION PORTAL |
Applicant |
INVIVO CORPORATION |
12151 RESEARCH PKWY |
ORLANDO,
FL
32826
|
|
Applicant Contact |
RUSTY KELLY |
Correspondent |
INVIVO CORPORATION |
12151 RESEARCH PKWY |
ORLANDO,
FL
32826
|
|
Correspondent Contact |
RUSTY KELLY |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 05/14/2012 |
Decision Date | 06/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|