ULTRA BILI LIGHT
Unit, Neonatal Phototherapy
PHYSICIAN ENGINEERED PRODUCTS, INC.
The following data is part of a premarket notification filed by Physician Engineered Products, Inc. with the FDA for Ultra Bili Light.
Pre-market Notification Details
| Device ID | K974830 |
| 510k Number | K974830 |
| Device Name: | ULTRA BILI LIGHT |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | PHYSICIAN ENGINEERED PRODUCTS, INC. 420 WEST SECOND ST. Park Rapids, MN 56470 |
| Contact | Robert J Rose |
| Correspondent | Robert J Rose PHYSICIAN ENGINEERED PRODUCTS, INC. 420 WEST SECOND ST. 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 | 1997-12-24 |
| Decision Date | 1998-05-20 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00183415000107 | K974830 | 000 |
Trademark Results [ULTRA BILI LIGHT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRA BILI LIGHT 75660426 not registered Dead/Abandoned |
Physician Engineered Products Inc. 1999-03-15 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.