K100268 is an FDA 510(k) clearance for the SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER. This device is classified as a Chamber, Hyperbaric (Class II - Special Controls, product code CBF).
Submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on April 26, 2010, 87 days after receiving the submission on January 29, 2010.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5470.
| 510(k) Number | K100268 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2010 |
| Decision Date | April 26, 2010 |
| Days to Decision | 87 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CBF — Chamber, Hyperbaric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5470 |