Cleared Traditional

K864186 - HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT) (FDA 510(k) Clearance)

Nov 1986
Decision
17d
Days
Class 2
Risk

K864186 is an FDA 510(k) clearance for the HILL-ROM CENTURY CC MODELS 892 &894 (RADIOLUCENT). 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, 17 days after receiving the submission on October 27, 1986.

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

Submission Details

510(k) Number K864186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1986
Decision Date November 13, 1986
Days to Decision 17 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