The following data is part of a premarket notification filed by Fanem Lda with the FDA for Infant Phototherapy Bilitron Sky 5006.
| Device ID | K131196 |
| 510k Number | K131196 |
| Device Name: | INFANT PHOTOTHERAPY BILITRON SKY 5006 |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | FANEM LDA 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad FANEM LDA 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-26 |
| Decision Date | 2014-02-20 |
| Summary: | summary |