Device Classification Name |
Oximeter
|
510(k) Number |
K941351 |
Device Name |
BURDICK PRO2 OXIMETER |
Applicant |
BURDICK CORP. |
15 PLUMB ST. |
MILTON,
WI
53563
|
|
Applicant Contact |
PAUL E APPEL |
Correspondent |
BURDICK CORP. |
15 PLUMB ST. |
MILTON,
WI
53563
|
|
Correspondent Contact |
PAUL E APPEL |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 03/22/1994 |
Decision Date | 10/13/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|