O.S.C.A.R. (Operating System for Control and Record Keeping)

FDA 510(k) K092991 · Environmental Tectonics Corp.

Substantially Equivalent

510(k) numberK092991

Submission

Device name
O.S.C.A.R. (Operating System for Control and Record Keeping)
Applicant
Environmental Tectonics Corp.
Southampton, PA, US
Received
September 28, 2009
Decision date
August 13, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA
Third-party review
Yes

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

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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
K101262Flexi-LiteCBF · Traditional Pressure-Tech, Inc.06/10/2010SE
K100268Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special Sechrist Industries, Inc.04/26/2010SE
K082455Rectangular Multiplace Hyperbaric ChamberCBF · Traditional Gulf Coast Hyperbarics, Inc.05/22/2009SE

More from Gulf Coast Hyperbarics, Inc.

510(k)DeviceDecision
K020974Bara-Med Acrylic Monoplace Hyperbaric ChamberCBF · Traditional 06/26/2002SESU
K993010Bara-Med, Acrylic Monoplace Hyperbaric ChamberCBF · Traditional 05/30/2000SE

Questions and answers

When was O.S.C.A.R. (Operating System for Control and Record Keeping) cleared by the FDA?

O.S.C.A.R. (Operating System for Control and Record Keeping) (K092991) received a 510(k) decision of Substantially Equivalent on August 13, 2010, 319 days after the submission was received.

What is the product code of K092991?

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