Submission Details
| 510(k) Number | K954846 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 23, 1995 |
| Decision Date | December 14, 1995 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
K954846: OLYMPIC SMART SCALE
Dec 1995
Decision
52d
Days
Class 1
Risk
About This 510(k) Submission
K954846 is an FDA 510(k) clearance for the OLYMPIC SMART SCALE, 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, 52 days after receiving the submission on October 23, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2720.
Device Classification
| Product Code | FRW — Scale, Patient |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.2720 |
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