HTU3

FDA 510(k) K984313 · Hyox Systems , Ltd.

Substantially Equivalent

510(k) numberK984313

Submission

Device name
HTU3
Applicant
Hyox Systems , Ltd.
Washington, DC, US
Received
December 2, 1998
Decision date
October 22, 1999
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

Other 510(k)s with product code CBF

510(k)DeviceApplicantDecision
K240569FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberCBF · Traditional Fink Engineering Pty, Ltd.11/21/2024SE
K220290Revitalair 430+CBF · Traditional Us Hyperbaric Network05/04/2023SE
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 HTU3 cleared by the FDA?

HTU3 (K984313) received a 510(k) decision of Substantially Equivalent on October 22, 1999, 324 days after the submission was received.

What is the product code of K984313?

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