Device Classification Name |
Oximeter
|
510(k) Number |
K022163 |
Device Name |
WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 |
Applicant |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Applicant Contact |
DAVID KLEMENTOWSKI |
Correspondent |
WELCH ALLYN, INC. |
4341 STATE ST. RD. |
P.O. BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Correspondent Contact |
DAVID KLEMENTOWSKI |
Regulation Number | 870.2700
|
Classification Product Code |
|
Date Received | 07/03/2002 |
Decision Date | 09/17/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|