Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K101571 |
Device Name |
XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS |
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 |
|
Subsequent Product Code |
|
Date Received | 06/04/2010 |
Decision Date | 10/26/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|