The following data is part of a premarket notification filed by Medix I.c.s.a. with the FDA for Medix Phototherapy Lamp.
| Device ID | K931965 |
| 510k Number | K931965 |
| Device Name: | MEDIX PHOTOTHERAPY LAMP |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | MEDIX I.C.S.A. CALLE 89 JOSE ARIAS 293 San Martin, Buenos Aires, AR B1672aca |
| Contact | Carlos Guerra |
| Correspondent | Carlos Guerra MEDIX I.C.S.A. CALLE 89 JOSE ARIAS 293 San Martin, Buenos Aires, AR B1672aca |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-22 |
| Decision Date | 1993-12-09 |