The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Smart Scale Model 50/50ra.
| Device ID | K955357 |
| 510k Number | K955357 |
| Device Name: | OLYMPIC SMART SCALE MODEL 50/50RA |
| Classification | Scale, Patient |
| 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 | FRW |
| CFR Regulation Number | 880.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-23 |
| Decision Date | 1996-01-30 |