Voyager PX

FDA 510(k) K895082 · Smith-Perry Corp.

Substantially Equivalent

510(k) numberK895082

Submission

Device name
Voyager PX
Applicant
Smith-Perry Corp.
Riviera Beach, FL, US
Received
August 14, 1989
Decision date
January 9, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BYJ – Unit, Liquid-Oxygen, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5655
Specialty
Anesthesiology

Other 510(k)s with product code BYJ

510(k)DeviceApplicantDecision
K130068Dismounted Medical & Supplemental Oxygen System (Dmos)BYJ · Traditional Essex Industries, Inc. D/B/A Essex Cryogenics of M07/19/2013SE
K113767Mounted Medical Oxygen SystemBYJ · Traditional Essex Industries, Inc.06/29/2012SE
K103324Precision Liquid Oxygen SystemBYJ · Traditional Precision Medical, Inc.04/21/2011SE
K101272Mass Oxygen Distribution System (Mods) Model 10C-0061-3BYJ · Traditional Essex Industries, Inc.08/20/2010SE
K081779GOLOX-93BYJ · Traditional Respironics, Inc.09/19/2008SE
K080023Modification to: SpiritBYJ · Special Caire, Inc.06/16/2008SE
K072723Respironics GoloxBYJ · Traditional Respironics, Inc.03/20/2008SE
K072011Copd Liquid Oxygen Portable, Model 300PBYJ · Traditional Copd Partners, Inc.10/18/2007SE
K071581Backpack Medical Oxygen SystemBYJ · Traditional Essex Cryogenics of Missouri, Inc.07/11/2007SE
K050153Spirit, Model HasBYJ · Traditional Caire, Inc.04/15/2005SE

More from Caire, Inc.

510(k)DeviceDecision
K884754Voyager/XNFB · Traditional 01/04/1989SE

Questions and answers

When was Voyager PX cleared by the FDA?

Voyager PX (K895082) received a 510(k) decision of Substantially Equivalent on January 9, 1990, 148 days after the submission was received.

What is the product code of K895082?

The FDA product code is BYJ – Unit, Liquid-Oxygen, Portable, a Class II (moderate risk) device regulated under 21 CFR 868.5655.