Cleared Traditional

OLYMPIC SMART SCALE MODEL 50/50RA

K955357 · Olympic Medical Corp. · General Hospital
Jan 1996
Decision
99d
Days
Class 1
Risk

About This 510(k) Submission

K955357 is an FDA 510(k) clearance for the OLYMPIC SMART SCALE MODEL 50/50RA, a Scale, Patient (Class I — General Controls, product code FRW), submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on January 30, 1996, 99 days after receiving the submission on October 23, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2720.

Submission Details

510(k) Number K955357 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1995
Decision Date January 30, 1996
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRW — Scale, Patient
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.2720