The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Bili-meter(tm) With Type-f Sensor.
| Device ID | K903445 |
| 510k Number | K903445 |
| Device Name: | OLYMPIC BILI-METER(TM) WITH TYPE-F SENSOR |
| Classification | Unit, Neonatal Phototherapy |
| Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Contact | Ken Thomas |
| Correspondent | Ken Thomas 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 | 1990-07-31 |
| Decision Date | 1990-10-29 |