The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Bili-lite.
| Device ID | K940996 |
| 510k Number | K940996 |
| Device Name: | OLYMPIC BILI-LITE |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Contact | Joseph P Stefanile |
| Correspondent | Joseph P Stefanile OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Product Code | LBI |
| CFR Regulation Number | 880.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-04 |
| Decision Date | 1994-09-16 |