Cleared Traditional

K864172 - HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS (FDA 510(k) Clearance)

Nov 1986
Decision
20d
Days
Class 2
Risk

K864172 is an FDA 510(k) clearance for the HILL-ROM CENTURY CC, MODELS 891 & 893 WEIGHING SYS. This device is classified as a Bed, Ac-powered Adjustable Hospital (Class II - Special Controls, product code FNL).

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on November 13, 1986, 20 days after receiving the submission on October 24, 1986.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5100.

Submission Details

510(k) Number K864172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1986
Decision Date November 13, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code FNL — Bed, Ac-powered Adjustable Hospital
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5100