Device Classification Name |
Oximeter
|
510(k) Number |
K031740 |
Device Name |
VSM - VITAL SIGNS MONITOR, MODEL 53000 SERIES |
Applicant |
WELCH ALLYN PROTOCOL, INC. |
8500 S.W. CREEKSIDE PLACE |
BEAVERTON,
OR
97008 -7107
|
|
Applicant Contact |
JAMES W SANDBERG |
Correspondent |
WELCH ALLYN PROTOCOL, INC. |
8500 S.W. CREEKSIDE PLACE |
BEAVERTON,
OR
97008 -7107
|
|
Correspondent Contact |
JAMES W SANDBERG |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 06/04/2003 |
Decision Date | 08/26/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|