K993410 is an FDA 510(k) clearance for the DATES-OHMEDA AESTIVA SMARTVENT MRI. 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 April 25, 2000, 196 days after receiving the submission on October 12, 1999.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K993410 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1999 |
| Decision Date | April 25, 2000 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| 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 |