Cleared Traditional

WARM-SCALE

K952649 · Olympic Medical Corp. · General Hospital
Aug 1995
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K952649 is an FDA 510(k) clearance for the WARM-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 August 15, 1995, 67 days after receiving the submission on June 9, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2720.

Submission Details

510(k) Number K952649 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1995
Decision Date August 15, 1995
Days to Decision 67 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