Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K063840 |
Device Name |
XPER INFORMATION MANAGEMENT/PHYSIOMONITORING 5 SYSTEM AND/OR VASCULAR 5, PATIENT CARE CONSOLE AND CENTRAL STATION |
Applicant |
WITT BIOMEDICAL CORP |
305 NORTH DR. |
MELBOURNE,
FL
32934
|
|
Applicant Contact |
JAMES LUKER |
Correspondent |
WITT BIOMEDICAL CORP |
305 NORTH DR. |
MELBOURNE,
FL
32934
|
|
Correspondent Contact |
JAMES LUKER |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 12/26/2006 |
Decision Date | 02/06/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|