The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Smart Scale Care Center.
| Device ID | K920423 |
| 510k Number | K920423 |
| Device Name: | OLYMPIC SMART SCALE CARE CENTER |
| Classification | Catheter, Malecot |
| 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 | FEW |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-31 |
| Decision Date | 1992-06-11 |