K013251 is an FDA 510(k) clearance for the SPIRIT 300. This device is classified as a Unit, Liquid-oxygen, Portable (Class II - Special Controls, product code BYJ).
Submitted by Caire, Inc. (Burnsville, US). The FDA issued a Cleared decision on December 18, 2001, 81 days after receiving the submission on September 28, 2001.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5655.
| 510(k) Number | K013251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 28, 2001 |
| Decision Date | December 18, 2001 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BYJ - Unit, Liquid-oxygen, Portable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5655 |