The following data is part of a premarket notification filed by Physician Engineered Products, Inc. with the FDA for Bili-mirror Model Blm-1.
| Device ID | K093618 |
| 510k Number | K093618 |
| Device Name: | BILI-MIRROR MODEL BLM-1 |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | PHYSICIAN ENGINEERED PRODUCTS, INC. 103 SMITH ST. Fryeburg, ME 04037 |
| Contact | Rob Rose, Md |
| Correspondent | Rob Rose, Md 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 | 2009-11-23 |
| Decision Date | 2010-04-23 |
| Summary: | summary |