Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
FDA 510(k) K152223 · Oxyheal Medical Systems, Inc.
510(k) numberK152223
Submission
- Device name
- Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
- Applicant
- Oxyheal Medical Systems, Inc.
National City, CA, US - Received
- August 7, 2015
- Decision date
- April 29, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K240569 | FESL FINK Chamber; FEDL FINK Chamber; FETL FINK ChamberCBF · Traditional | Fink Engineering Pty, Ltd. | 11/21/2024SE |
| K220290 | Revitalair 430+CBF · Traditional | Us Hyperbaric Network | 05/04/2023SE |
| K171899 | Revitalair 430FCBF · Traditional | Oxavita Srl | 11/22/2019SE |
| K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyCBF · Special | Oxyheal Medical Systems, Inc. | 03/22/2017SE |
| K140559 | Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special | Sechrist Industries, Inc. | 05/30/2014SE |
| K102831 | Rsi 4200CBF · Abbreviated | Reimers Systems, Inc. | 08/19/2011SE |
| K092991 | O.S.C.A.R. (Operating System for Control and Record Keeping)CBF · Traditional | Environmental Tectonics Corp. | 08/13/2010SE |
| K101262 | Flexi-LiteCBF · Traditional | Pressure-Tech, Inc. | 06/10/2010SE |
| K100268 | Sechrist Monoplace Hyperbaric Oxygen ChamberCBF · Special | Sechrist Industries, Inc. | 04/26/2010SE |
| K082455 | Rectangular Multiplace Hyperbaric ChamberCBF · Traditional | Gulf Coast Hyperbarics, Inc. | 05/22/2009SE |
More from Gulf Coast Hyperbarics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K163109 | OxyHeal 4000 Multiplace Hyperbaric Chamber FamilyCBF · Special | 03/22/2017SE |
Questions and answers
When was Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System cleared by the FDA?
Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System (K152223) received a 510(k) decision of Substantially Equivalent on April 29, 2016, 266 days after the submission was received.
What is the product code of K152223?
The FDA product code is CBF – Chamber, Hyperbaric, a Class II (moderate risk) device regulated under 21 CFR 868.5470.