The following data is part of a premarket notification filed by Lantos Technologies with the FDA for Lantos 3d Ear Scanner.
| Device ID | K121326 |
| 510k Number | K121326 |
| Device Name: | LANTOS 3D EAR SCANNER |
| Classification | Otoscope |
| Applicant | LANTOS TECHNOLOGIES 20310 SW 48TH ST Southwest Ranches, FL 33332 |
| Contact | John Greenbaum |
| Correspondent | John Greenbaum LANTOS TECHNOLOGIES 20310 SW 48TH ST Southwest Ranches, FL 33332 |
| Product Code | ERA |
| CFR Regulation Number | 874.4770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-02 |
| Decision Date | 2013-01-25 |
| Summary: | summary |