Device Classification Name |
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
|
510(k) Number |
K061590 |
Device Name |
SMDIE DEVICE INTERFACING SYSTEM |
Applicant |
SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT |
2454 MCMULLEN BOOTH ROAD |
SUITE 427 |
CLEARWATER,
FL
33759
|
|
Applicant Contact |
IAN GORDON |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 870.2300
|
Classification Product Code |
|
Date Received | 06/08/2006 |
Decision Date | 06/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|