The following data is part of a premarket notification filed by Oxyheal Medical Systems, Inc. with the FDA for Oxyheal 4000 Multiplace Hyperbaric Chamber Family.
| Device ID | K163109 |
| 510k Number | K163109 |
| Device Name: | OxyHeal 4000 Multiplace Hyperbaric Chamber Family |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-07 |
| Decision Date | 2017-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006478926 | K163109 | 000 |