Device Classification Name |
Transmitters And Receivers, Physiological Signal, Radiofrequency
|
510(k) Number |
K122095 |
Device Name |
ICP TRIAGEMANAGER |
Applicant |
Emergo Europe Consulting BV |
PRINSESSEGRACHT 20 |
DEN HAAG,
NL
2514
|
|
Applicant Contact |
RACHIDA ZIANI |
Correspondent |
DEKRA CERTIFICATION B.V. |
UTRECHTSEWEG 310 |
ARNHEM,
NL
NL-6812 AR
|
|
Correspondent Contact |
J.A. VAN VUGT |
Regulation Number | 870.2910
|
Classification Product Code |
|
Date Received | 07/12/2012 |
Decision Date | 07/26/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|