The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Bili-dosimeter.
| Device ID | K791114 |
| 510k Number | K791114 |
| Device Name: | BILI-DOSIMETER |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | OLYMPIC MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-06-15 |
| Decision Date | 1979-09-04 |