Device Classification Name |
monitor, physiological, patient (without arrhythmia detection or alarms)
|
510(k) Number |
K063419 |
Device Name |
MODIFICATION TO VSM- VITAL SIGNS MONITOR, (VSM 300 ) |
Applicant |
WELCH ALLYN PROTOCOL, INC. |
8500 S.W. CREEKSIDE PLACE |
BEAVERTON,
OR
97008 -7107
|
|
Applicant Contact |
JEFFREY WAGNER |
Correspondent |
WELCH ALLYN PROTOCOL, INC. |
8500 S.W. CREEKSIDE PLACE |
BEAVERTON,
OR
97008 -7107
|
|
Correspondent Contact |
JEFFREY WAGNER |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 11/13/2006 |
Decision Date | 12/04/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|