K002878 is an FDA 510(k) clearance for the DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER. 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 September 21, 2000, 6 days after receiving the submission on September 15, 2000.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5880.
| 510(k) Number | K002878 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2000 |
| Decision Date | September 21, 2000 |
| Days to Decision | 6 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 |