K831825 is an FDA 510(k) clearance for the DISPOS. HYPERBARIC OXYGEN CUSH/TRAUM. This device is classified as a Chamber, Oxygen, Topical, Extremity (Class II - Special Controls, product code KPJ).
Submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1983, 142 days after receiving the submission on June 7, 1983.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.5650.
| 510(k) Number | K831825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 1983 |
| Decision Date | October 27, 1983 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| Product Code | KPJ — Chamber, Oxygen, Topical, Extremity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5650 |