Cleared Traditional

K940245 - EVACU-SLED
(FDA 510(k) Clearance)

K940245 · Evacu Technologies, Inc. · General Hospital
Feb 1994
Decision
40d
Days
Class 1
Risk

K940245 is an FDA 510(k) clearance for the EVACU-SLED, a Stretcher, Hand-carried (Class I — General Controls, product code FPP), submitted by Evacu Technologies, Inc. (Ontario Canada L4y 2s9, CA). The FDA issued a Cleared decision on February 28, 1994, 40 days after receiving the submission on January 19, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6900.

Submission Details

510(k) Number K940245 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1994
Decision Date February 28, 1994
Days to Decision 40 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPP — Stretcher, Hand-carried
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6900