The following data is part of a premarket notification filed by Oxyheal Medical Systems, Inc. with the FDA for Rectangular Multiplace Hyperbaric Chamber System Product Family With Touchscreen Control System.
| Device ID | K152223 |
| 510k Number | K152223 |
| Device Name: | Rectangular Multiplace Hyperbaric Chamber System Product Family With Touchscreen Control System |
| Classification | Chamber, Hyperbaric |
| Applicant | OXYHEAL MEDICAL SYSTEMS, INC. 3224 HOOVER AVE. National City, CA 91950 |
| Contact | Edward J Chomas |
| Correspondent | Edward J Chomas OXYHEAL MEDICAL SYSTEMS, INC. 3224 HOOVER AVE. National City, CA 91950 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-07 |
| Decision Date | 2016-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006478902 | K152223 | 000 |
| 00860006478919 | K152223 | 000 |