Evacu-Sled

FDA 510(k) K940245 · Evacu Technologies, Inc.

Substantially Equivalent

510(k) numberK940245

Submission

Device name
Evacu-Sled
Applicant
Evacu Technologies, Inc.
Ontario Canada L4y 2s9, CA
Received
January 19, 1994
Decision date
February 28, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FPP – Stretcher, Hand-Carried
Device class
Class I (low risk)
Regulation
21 CFR 880.6900
Specialty
General Hospital

Other 510(k)s with product code FPP

510(k)DeviceApplicantDecision
K030283Baby PodFPP · Traditional Prism Enterprises, Inc.04/22/2003SE
K942356MED-EVAC-4 Medical Evacuation StretcherFPP · Traditional Montery Bay Corp.07/19/1994SE
K940130Stryker Model 6110 Emergency/Pole StretcherFPP · Traditional Stryker Corp.03/10/1994SE
K924275Restraining StretcherFPP · Traditional Dms07/27/1993SE
K922816U P Custom Design, Inc. Cot Equipment CarrierFPP · Traditional Up Custom Design, Inc.07/13/1993SE
K924669Ferno-Washington Basket Stretcher, Model 71-WFPP · Traditional Ferno04/29/1993SE
K920805Life Lite Emergency StretcherFPP · Traditional Design Principles, Inc.05/22/1992SE
K915874Basket Litter CarrierFPP · Traditional Bradco Med , Ltd.05/13/1992SE
K914140Grassi Gastrojejun Tube Gastric Decomp/Jejun FeedFPP · Traditional Bissell Medical Products, Inc.03/31/1992SE
K913520Evacu SledFPP · Traditional Nexus Health Care Products , Ltd.12/04/1991SE

Questions and answers

When was Evacu-Sled cleared by the FDA?

Evacu-Sled (K940245) received a 510(k) decision of Substantially Equivalent on February 28, 1994, 40 days after the submission was received.

What is the product code of K940245?

The FDA product code is FPP – Stretcher, Hand-Carried, a Class I (low risk) device regulated under 21 CFR 880.6900.