Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
FDA 510(k) clearance K152223 · decided 2016-04-29
Clearance details
- K-number
- K152223
- Device name
- Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
- Applicant
- Oxyheal Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-07
- Decision date
- 2016-04-29
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- CBF
- Device class
- 2
- Regulation number
- 868.5470
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- National City, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (K240569) | Fink Engineering Pty, Ltd. | 2024-11-21 |
| Revitalair 430+ (K220290) | Us Hyperbaric Network | 2023-05-04 |
| Revitalair 430F (K171899) | Oxavita Srl | 2019-11-22 |
| OxyHeal 4000 Multiplace Hyperbaric Chamber Family (K163109) | Oxyheal Medical Systems, Inc. | 2017-03-22 |
| SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (K140559) | Sechrist Industries, Inc. | 2014-05-30 |
| RSI 4200 (K102831) | Reimers Systems, Inc. | 2011-08-19 |
| O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING) (K092991) | Environmental Tectonics Corp. | 2010-08-13 |
| FLEXI-LITE (K101262) | Pressure-Tech, Inc. | 2010-06-10 |
| SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER (K100268) | Sechrist Industries, Inc. | 2010-04-26 |
| RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER (K082455) | Gulf Coast Hyperbarics, Inc. | 2009-05-22 |
| HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS (K081506) | Hyperbaric America, LLC | 2008-07-25 |
| SIGMA SERIES HYPERBARIC CHAMBER (K072427) | Perry Baromedical Corp. | 2008-06-11 |
Recalls involving this device
No recalls on record reference this clearance.