The following data is part of a premarket notification filed by Physician Engineered Products, Inc. with the FDA for Home Bili Lights-model 100.
Device ID | K850599 |
510k Number | K850599 |
Device Name: | HOME BILI LIGHTS-MODEL 100 |
Classification | Unit, Neonatal Phototherapy |
Applicant | PHYSICIAN ENGINEERED PRODUCTS, INC. HCO6 BOX 17 Park Rapids, MN 56470 |
Contact | Rose |
Correspondent | Rose PHYSICIAN ENGINEERED PRODUCTS, INC. HCO6 BOX 17 Park Rapids, MN 56470 |
Product Code | LBI |
CFR Regulation Number | 880.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-15 |
Decision Date | 1985-06-17 |