Device Classification Name |
Oximeter
|
510(k) Number |
K103700 |
Device Name |
ESSENTIAL MRI PATIENT MONITOR |
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 | 870.2700
|
Classification Product Code |
|
Date Received | 12/20/2010 |
Decision Date | 03/15/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|