Device Classification Name |
hyperthermia monitor
|
510(k) Number |
K100071 |
Device Name |
EMCOOLSPAD |
Applicant |
EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG |
BRUCKNERSTRASSE 6/7A |
1040 WIEN |
VIENNA,
AT
1040
|
|
Applicant Contact |
MICHAEL KUEHLING |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
STEFAN PREISS |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 01/11/2010 |
Decision Date | 10/12/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|