K092864 is an FDA 510(k) clearance for the AESPIRE 7900, AESPIRE VIEW. This device is classified as a Gas-machine, Anesthesia (Class II - Special Controls, product code BSZ).
Submitted by Datex-Ohmeda Inc., A Division of Instrumentarium C (Madison, US). The FDA issued a Cleared decision on January 12, 2010, 117 days after receiving the submission on September 17, 2009.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K092864 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2009 |
| Decision Date | January 12, 2010 |
| Days to Decision | 117 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSZ — Gas-machine, Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5160 |