The following data is part of a premarket notification filed by Hyperbaric Technologies, Inc. with the FDA for Oxyheal 2000 Hyperbaric Chamber Series, Model Oxyheal 2000 Series.
| Device ID | K011866 |
| 510k Number | K011866 |
| Device Name: | OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES |
| Classification | Chamber, Hyperbaric |
| Applicant | HYPERBARIC TECHNOLOGIES, INC. 3224 HOOVER AVE. National City, CA 91950 |
| Contact | Dave Heaney |
| Correspondent | Dave Heaney HYPERBARIC TECHNOLOGIES, INC. 3224 HOOVER AVE. National City, CA 91950 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-14 |
| Decision Date | 2002-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006478940 | K011866 | 000 |