K031649 is an FDA 510(k) clearance for the SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES. This device is classified as a Chamber, Hyperbaric (Class II - Special Controls, product code CBF).
Submitted by Fink Engineering Pty, Ltd. (San Antonio, US). The FDA issued a Cleared decision on December 5, 2003, 191 days after receiving the submission on May 28, 2003.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5470.
| 510(k) Number | K031649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2003 |
| Decision Date | December 05, 2003 |
| Days to Decision | 191 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBF - Chamber, Hyperbaric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5470 |