Vail 3000 Bed Enclosure

FDA 510(k) K963589 · Vail Products, Inc.

Substantially Equivalent

510(k) numberK963589

Submission

Device name
Vail 3000 Bed Enclosure
Applicant
Vail Products, Inc.
Toledo, OH, US
Received
September 9, 1996
Decision date
April 21, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
FNL – Bed, Ac-Powered Adjustable Hospital
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5100
Specialty
General Hospital

Other 510(k)s with product code FNL

510(k)DeviceApplicantDecision
K202964iBed Wireless with iBed MobileFNL · Traditional Stryker Corporation06/18/2021SE
K103536Ibed Wireless with Ibed AwarenessFNL · Traditional Stryker Corporation12/16/2010SE
K982783Vail 1000 Enclosed BedFNL · Traditional Vail Products, Inc.10/05/1998SE
K974296Model 720 Series Full/Semi Electric Bed 1120 Full Electric BedFNL · Traditional Invacare Corp.01/06/1998SE
K974254Benefit B3--- SeriesFNL · Traditional M.C. Healthcare Products, Inc.12/16/1997SE
K972115Volker Hospital Bed, Model K960FNL · Traditional Volker Healthcare, Inc.08/29/1997SE
K971546Soma 900 Transport BedFNL · Traditional Nova Technologies, Inc.07/10/1997SE
K963622Vail 2000 Enclosed BedFNL · Traditional Vail Products, Inc.05/07/1997SE
K962942TotalcareFNL · Traditional Hill-Rom, Inc.02/03/1997SE
K963701Soma Safe EnclosureFNL · Traditional Nova Technology Corp.01/24/1997SE

More from Nova Technology Corp.

510(k)DeviceDecision
K982783Vail 1000 Enclosed BedFNL · Traditional 10/05/1998SE
K963622Vail 2000 Enclosed BedFNL · Traditional 05/07/1997SE
K963210Vail 100 Pediatric CribFMS · Traditional 11/13/1996SE

Questions and answers

When was Vail 3000 Bed Enclosure cleared by the FDA?

Vail 3000 Bed Enclosure (K963589) received a 510(k) decision of Substantially Equivalent on April 21, 1997, 224 days after the submission was received.

What is the product code of K963589?

The FDA product code is FNL – Bed, Ac-Powered Adjustable Hospital, a Class II (moderate risk) device regulated under 21 CFR 880.5100.