Device Classification Name |
Densitometer, Bone
|
510(k) Number |
K121716 |
Device Name |
TBS INSIGHT |
Applicant |
MEDIMAPS GROUP SA |
18 CHEMIN DES AULX |
PLAN LES OUATES,
CH
1228
|
|
Applicant Contact |
CHRISTOPHE LELONG |
Correspondent |
MEDIMAPS GROUP SA |
18 CHEMIN DES AULX |
PLAN LES OUATES,
CH
1228
|
|
Correspondent Contact |
CHRISTOPHE LELONG |
Regulation Number | 892.1170
|
Classification Product Code |
|
Date Received | 06/11/2012 |
Decision Date | 10/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|