K955177 is an FDA 510(k) clearance for the OLYMPIC SMART SCALE. This device is classified as a Scale, Patient (Class I - General Controls, product code FRW).
Submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on December 14, 1995, 31 days after receiving the submission on November 13, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2720.
| 510(k) Number | K955177 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 1995 |
| Decision Date | December 14, 1995 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FRW — Scale, Patient |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.2720 |