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 |