Device Classification Name |
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
|
510(k) Number |
K082045 |
Device Name |
MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220 |
Applicant |
SPACELABS MEDICAL INC. |
2235 EAST FLAMINGO RD. |
SUITE 201G |
LAS VEGAS,
NV
89119
|
|
Applicant Contact |
TIM DAVIS |
Correspondent |
SPACELABS MEDICAL INC. |
2235 EAST FLAMINGO RD. |
SUITE 201G |
LAS VEGAS,
NV
89119
|
|
Correspondent Contact |
TIM DAVIS |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 07/18/2008 |
Decision Date | 08/01/2008 |
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
|
|
|