Device Classification Name |
monitor, physiological, patient(with arrhythmia detection or alarms)
|
510(k) Number |
K150329 |
Device Name |
elance Vital Signs Monitor, Central Monitor Software |
Applicant |
SPACELABS HEALTHCARE |
35301 SE CENTER STREET |
SNOQUALMIE,
WA
98065
|
|
Applicant Contact |
Al Van Houdt |
Correspondent |
Speed to Market, Inc. |
PO Box 3018 |
Nederland,
CO
80466
|
|
Correspondent Contact |
Thomas Kroenke |
Regulation Number | 870.1025
|
Classification Product Code |
|
Date Received | 02/10/2015 |
Decision Date | 11/05/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|