510(k) K152223
- Device
- Rectangular Multiplace Hyperbaric Chamber System Product Family With Touchscreen Control System
- Applicant
- OXYHEAL MEDICAL SYSTEMS, INC.
- 510(k) number
- K152223
- Product code
- CBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-04-29
- Date received
- 2015-08-07
- Regulation
- 868.5470
- Classification name
- Chamber, Hyperbaric
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Edward J Chomas
- Address
- 3224 Hoover Ave. National City CA US 91950 91950
FDA Registration Numbers#
- 3013938915
- 3016489995
- 3013595329
- 3006097795
- 1036464
- 3006777109
- 3004035771
- 2020676
- 1000402893
- 3007127387
- 3010317211
- 3005505220
- 8043539
- 3013976593
- 3007319244
- 3016467917
- 2438426
- 1000519737
Source Documents#
Other 510(k) Records For Product Code CBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber | Fink Engineering Pty, Ltd. | 2024-11-21 |
| K220290 | Revitalair 430+ | Us Hyperbaric Network | 2023-05-04 |
| K171899 | Revitalair 430F | Oxavita Srl | 2019-11-22 |
| K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber Family | Oxyheal Medical Systems, Inc. | 2017-03-22 |
| K140559 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | 2014-05-30 |
| K102831 | RSI 4200 | Reimers Systems, Inc. | 2011-08-19 |
| K092991 | O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) | Environmental Tectonics Corp. | 2010-08-13 |
| K101262 | FLEXI-LITE | Pressure-Tech, Inc. | 2010-06-10 |
| K100268 | SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER | Sechrist Industries, Inc. | 2010-04-26 |
| K082455 | RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER | Gulf Coast Hyperbarics, Inc. | 2009-05-22 |
| K081506 | HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS | Hyperbaric America, LLC | 2008-07-25 |
| K072427 | SIGMA SERIES HYPERBARIC CHAMBER | Perry Baromedical Corp. | 2008-06-11 |
| K072757 | DIVE AND SHALLOW AND GRAND DIVE | Summit TO Sea | 2008-02-08 |
| K060739 | MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 | Khrunichev State Research & Production Space Centr | 2006-07-21 |
| K053498 | HYPEROX 101 | Wjo, Inc. | 2006-03-15 |
Legacy Summary#
summary
FDA Review#
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