K050055 is an FDA 510(k) clearance for the GE DATEX-OHMEDA AESTIVA/5 MRI ANESTHESIA SYSTEM. This device is classified as a Gas-machine, Anesthesia (Class II - Special Controls, product code BSZ).
Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on February 4, 2005, 24 days after receiving the submission on January 11, 2005.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K050055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2005 |
| Decision Date | February 04, 2005 |
| Days to Decision | 24 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 |