U P Custom Design, Inc. Cot Equipment Carrier

FDA 510(k) K922816 · Up Custom Design, Inc.

Substantially Equivalent

510(k) numberK922816

Submission

Device name
U P Custom Design, Inc. Cot Equipment Carrier
Applicant
Up Custom Design, Inc.
Menominee, MI, US
Received
June 11, 1992
Decision date
July 13, 1993
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
K940245Evacu-SledFPP · Traditional Evacu Technologies, Inc.02/28/1994SE
K924275Restraining StretcherFPP · Traditional Dms07/27/1993SE
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 U P Custom Design, Inc. Cot Equipment Carrier cleared by the FDA?

U P Custom Design, Inc. Cot Equipment Carrier (K922816) received a 510(k) decision of Substantially Equivalent on July 13, 1993, 397 days after the submission was received.

What is the product code of K922816?

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