Hyperox 101

FDA 510(k) K053498 · Wjo, Inc.

Substantially Equivalent

510(k) numberK053498

Submission

Device name
Hyperox 101
Applicant
Wjo, Inc.
Bristol, PA, US
Received
December 16, 2005
Decision date
March 15, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CBF – Chamber, Hyperbaric
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5470
Specialty
Anesthesiology
Life-sustaining
Yes

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K171899Revitalair 430FCBF · Traditional Oxavita Srl11/22/2019SE
K163109OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyCBF · Special Oxyheal Medical Systems, Inc.03/22/2017SE
K152223Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control…CBF · Traditional Oxyheal Medical Systems, Inc.04/29/2016SE
K140559Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special Sechrist Industries, Inc.05/30/2014SE
K102831Rsi 4200CBF · Abbreviated Reimers Systems, Inc.08/19/2011SE
K092991O.S.C.A.R. (Operating System for Control and Record Keeping)CBF · Traditional Environmental Tectonics Corp.08/13/2010SE
K101262Flexi-LiteCBF · Traditional Pressure-Tech, Inc.06/10/2010SE
K100268Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special Sechrist Industries, Inc.04/26/2010SE

Questions and answers

When was Hyperox 101 cleared by the FDA?

Hyperox 101 (K053498) received a 510(k) decision of Substantially Equivalent on March 15, 2006, 89 days after the submission was received.

What is the product code of K053498?

The FDA product code is CBF – Chamber, Hyperbaric, a Class II (moderate risk) device regulated under 21 CFR 868.5470.