Device Classification Name |
otoscope
|
510(k) Number |
K121326 |
FOIA Releasable 510(k) |
K121326
|
Device Name |
LANTOS 3D EAR SCANNER |
Applicant |
LANTOS TECHNOLOGIES |
20310 SW 48TH ST |
SOUTHWEST RANCHES,
FL
33332
|
|
Applicant Contact |
JOHN GREENBAUM |
Correspondent |
LANTOS TECHNOLOGIES |
20310 SW 48TH ST |
SOUTHWEST RANCHES,
FL
33332
|
|
Correspondent Contact |
JOHN GREENBAUM |
Regulation Number | 874.4770
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/02/2012 |
Decision Date | 01/25/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|