The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Bili-meter.
| Device ID | K953005 |
| 510k Number | K953005 |
| Device Name: | BILI-METER |
| Classification | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Contact | Joseph Stefanile |
| Correspondent | Joseph Stefanile OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Product Code | JJQ |
| CFR Regulation Number | 862.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-28 |
| Decision Date | 1995-09-28 |