The following data is part of a premarket notification filed by Medix I.c.s.a. with the FDA for Medix Pc-305 Neonatal Incubator.
| Device ID | K920049 |
| 510k Number | K920049 |
| Device Name: | MEDIX PC-305 NEONATAL INCUBATOR |
| Classification | Incubator, Neonatal |
| 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 | FMZ |
| CFR Regulation Number | 880.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-06 |
| Decision Date | 1993-05-21 |