Device Classification Name |
oximeter, reprocessed
|
510(k) Number |
K101280 |
Device Name |
MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE |
Applicant |
MIDWEST REPROCESSING CENTER LLC |
434 INDUSTRIAL LANE |
BIRMINGHAM,
AL
35211
|
|
Applicant Contact |
JEROME JAMES |
Correspondent |
MIDWEST REPROCESSING CENTER LLC |
434 INDUSTRIAL LANE |
BIRMINGHAM,
AL
35211
|
|
Correspondent Contact |
JEROME JAMES |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 05/06/2010 |
Decision Date | 10/07/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|