The following data is part of a premarket notification filed by Physician Engineered Products, Inc. with the FDA for Bright Embrace Model Sbl60.
| Device ID | K110550 |
| 510k Number | K110550 |
| Device Name: | BRIGHT EMBRACE MODEL SBL60 |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | PHYSICIAN ENGINEERED PRODUCTS, INC. 103 SMITH ST. Fryeburg, ME 04037 |
| Contact | Robert Rose |
| Correspondent | Robert Rose PHYSICIAN ENGINEERED PRODUCTS, INC. 103 SMITH ST. Fryeburg, ME 04037 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-25 |
| Decision Date | 2012-02-03 |
| Summary: | summary |