The following data is part of a premarket notification filed by Hospitak, Inc. with the FDA for Dispos. Hyperbaric Oxygen Cush/traum.
| Device ID | K831825 |
| 510k Number | K831825 |
| Device Name: | DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | HOSPITAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-07 |
| Decision Date | 1983-10-27 |