Cleared Traditional

K952447 - HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER (FDA 510(k) Clearance)

Nov 1995
Decision
181d
Days
Class 2
Risk

K952447 is an FDA 510(k) clearance for the HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER. This device is classified as a Stretcher, Wheeled (Class II - Special Controls, product code FPO).

Submitted by Hill-Rom, Inc. (Batesville, US). The FDA issued a Cleared decision on November 22, 1995, 181 days after receiving the submission on May 25, 1995.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6910.

Submission Details

510(k) Number K952447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1995
Decision Date November 22, 1995
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FPO — Stretcher, Wheeled
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.6910