Device Classification Name |
Neurological Stereotaxic Instrument
|
510(k) Number |
K061479 |
Device Name |
ARGOS |
Applicant |
3D LINE MEDICAL SYSTEMS S.R.L. |
VIA BERNARDO RUCELLAI 23 |
MILAN,
IT
20161
|
|
Applicant Contact |
MARCO LUZZARA |
Correspondent |
TUV AMERICA, INC. |
1775 OLD HIGHWAY 8 |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
STEFAN PREISS |
Regulation Number | 882.4560
|
Classification Product Code |
|
Date Received | 05/30/2006 |
Decision Date | 04/05/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|