Device Classification Name |
oximeter
|
510(k) Number |
K032831 |
Device Name |
PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200 |
Applicant |
CONMED CORPORATION |
525 FRENCH ROAD |
UTICA,
NY
13502
|
|
Applicant Contact |
IRA DUESLER |
Correspondent |
CONMED CORPORATION |
525 FRENCH ROAD |
UTICA,
NY
13502
|
|
Correspondent Contact |
IRA DUESLER |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 09/11/2003 |
Decision Date | 08/31/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|