Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K090556 |
Device Name |
SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE |
Applicant |
SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO |
P.O. BOX 3018 |
NEDERLAND,
CO
80466
|
|
Applicant Contact |
THOMAS KROENKE |
Correspondent |
SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO |
P.O. BOX 3018 |
NEDERLAND,
CO
80466
|
|
Correspondent Contact |
THOMAS KROENKE |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 03/02/2009 |
Decision Date | 04/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|