The following data is part of a premarket notification filed by Infomed Servicios Informaticos S.l. with the FDA for Ortomed.
| Device ID | K131348 |
| 510k Number | K131348 |
| Device Name: | ORTOMED |
| Classification | System, Image Processing, Radiological |
| Applicant | INFOMED SERVICIOS INFORMATICOS S.L. VIA AUGUSTA 158, 4TH FLOOR Barcelona, ES 08006 |
| Contact | Santiago Sola |
| Correspondent | Santiago Sola INFOMED SERVICIOS INFORMATICOS S.L. VIA AUGUSTA 158, 4TH FLOOR Barcelona, ES 08006 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-10 |
| Decision Date | 2014-08-05 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTOMED 79169412 4911603 Live/Registered |
Infomed Servicios Informáticos, S.L. 2015-03-25 |