The Versa-Bed

FDA 510(k) K792298 · First & Ten, Inc.

Substantially Equivalent

510(k) numberK792298

Submission

Device name
The Versa-Bed
Applicant
First & Ten, Inc.
Mchenry, IL, US
Received
November 13, 1979
Decision date
December 20, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FNJ – Bed, Manual
Device class
Class I (low risk)
Regulation
21 CFR 880.5120
Specialty
General Hospital

Other 510(k)s with product code FNJ

510(k)DeviceApplicantDecision
K934298King KribFNJ · Traditional Noritage, Inc.01/26/1994SE
K892877Cradle, Hospital Bed ClothingFNJ · Traditional Warsaw Orthopedic, Inc.06/15/1989SE
K885241Bed, Adjustable, Hospital, Folding, Field, W/O MatFNJ · Traditional King Mfg. Co.02/24/1989SE
K884542Sic 3999 Folding Adjustable Hospital BedFNJ · Traditional Commercial Products & Engineering Co.11/21/1988SE
K881725Envirotent (Bed)FNJ · Traditional Envirotents, Inc.11/08/1988SE
K881961Msi Standard Bed Models: L1097-64 and L1085-64FNJ · Traditional Med Service, Inc.11/01/1988SE
K881964Msi 3003 Series BedFNJ · Traditional Med Service, Inc.06/28/1988SE
K881962Msi 2005 Series BedFNJ · Traditional Med Service, Inc.06/03/1988SE
K881043Folding Hospital Cot NSN 6530-00-299-8517FNJ · Traditional Junkin Safety Appliance Co., Inc.04/12/1988SE
K870166Platform Mattress W/Disposable Bedpan BagFNJ · Traditional George C. Kuhn03/13/1987SE

Questions and answers

When was The Versa-Bed cleared by the FDA?

The Versa-Bed (K792298) received a 510(k) decision of Substantially Equivalent on December 20, 1979, 37 days after the submission was received.

What is the product code of K792298?

The FDA product code is FNJ – Bed, Manual, a Class I (low risk) device regulated under 21 CFR 880.5120.