The following data is part of a premarket notification filed by Medix I.c.s.a. with the FDA for Mediled Phototherapy Lamp.
| Device ID | K083179 |
| 510k Number | K083179 |
| Device Name: | MEDILED PHOTOTHERAPY LAMP |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | MEDIX I.C.S.A. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss MEDIX I.C.S.A. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-28 |
| Decision Date | 2009-02-27 |
| Summary: | summary |