K000706 is an FDA 510(k) clearance for the DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR. 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 May 11, 2000, 70 days after receiving the submission on March 2, 2000.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5160.
| 510(k) Number | K000706 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2000 |
| Decision Date | May 11, 2000 |
| Days to Decision | 70 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 |