K031027 is an FDA 510(k) clearance for the DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE). This device is classified as a Vaporizer, Anesthesia, Non-heated (Class II - Special Controls, product code CAD).
Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on June 26, 2003, 86 days after receiving the submission on April 1, 2003.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5880.
| 510(k) Number | K031027 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2003 |
| Decision Date | June 26, 2003 |
| Days to Decision | 86 days |
| Submission Type | Special |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAD — Vaporizer, Anesthesia, Non-heated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5880 |