K080023 is an FDA 510(k) clearance for the MODIFICATION TO: SPIRIT. This device is classified as a Unit, Liquid-oxygen, Portable (Class II - Special Controls, product code BYJ).
Submitted by Caire, Inc. (Marietta, US). The FDA issued a Cleared decision on June 16, 2008, 164 days after receiving the submission on January 4, 2008.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5655.
| 510(k) Number | K080023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 04, 2008 |
| Decision Date | June 16, 2008 |
| Days to Decision | 164 days |
| Submission Type | Special |
| 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 |