Cleared Traditional

K940872 - PATIENT SUPPORT SYSTEM (FDA 510(k) Clearance)

Oct 1994
Decision
230d
Days
Class 2
Risk

K940872 is an FDA 510(k) clearance for the PATIENT SUPPORT SYSTEM. This device is classified as a Lift, Patient, Ac-powered (Class II - Special Controls, product code FNG).

Submitted by Arylift, Inc. (Washington, US). The FDA issued a Cleared decision on October 13, 1994, 230 days after receiving the submission on February 25, 1994.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5500.

Submission Details

510(k) Number K940872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1994
Decision Date October 13, 1994
Days to Decision 230 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FNG — Lift, Patient, Ac-powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5500