Device Classification Name |
system, thermal regulating
|
510(k) Number |
K093694 |
Device Name |
GERATHERM UNIQUERESC |
Applicant |
GERATHERM MEDICAL AG |
SCHWARZWALDSTRASSE 5 |
TUTTLIGEN,
DE
78532
|
|
Applicant Contact |
ANDREA PECSI |
Correspondent |
GERATHERM MEDICAL AG |
SCHWARZWALDSTRASSE 5 |
TUTTLIGEN,
DE
78532
|
|
Correspondent Contact |
ANDREA PECSI |
Regulation Number | 870.5900
|
Classification Product Code |
|
Date Received | 11/30/2009 |
Decision Date | 09/20/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|