The following data is part of a premarket notification filed by Medical Select, Inc. with the FDA for Bilibee Led Phototherapy System, Model: 1.
| Device ID | K072097 |
| 510k Number | K072097 |
| Device Name: | BILIBEE LED PHOTOTHERAPY SYSTEM, MODEL: 1 |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | MEDICAL SELECT, INC. 120 SOUTHCENTER CT., SUITE 400 Morrisville, NC 27560 |
| Contact | Amy Jones |
| Correspondent | Amy Jones MEDICAL SELECT, INC. 120 SOUTHCENTER CT., SUITE 400 Morrisville, NC 27560 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-31 |
| Decision Date | 2007-10-30 |
| Summary: | summary |