Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K090785 |
Device Name |
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 |
Applicant |
INVIVO CORP. |
12501 RESEARCH PARKWAY |
ORLANDO,
FL
32826
|
|
Applicant Contact |
RUSTY KELLY |
Correspondent |
INVIVO CORP. |
12501 RESEARCH PARKWAY |
ORLANDO,
FL
32826
|
|
Correspondent Contact |
RUSTY KELLY |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 03/23/2009 |
Decision Date | 12/15/2009 |
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
|
|
|