DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA— 510(k) K000275
Substantially EquivalentDatex-Ohmeda, Inc.
FDA 510(k) clearance K000275 for DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA, Substantially Equivalent on 2000-04-12. Applicant: Datex-Ohmeda, Inc.. Device class: 2.
Clearance details
- Applicant
- Datex-Ohmeda, Inc.
- Product code
- Code CAD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5880
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Madison, WI, US
Recent devices under product code CAD
view allMore clearances from Datex-Ohmeda, Inc.
view allAdverse events under product code CAD
product code CAD- Malfunction
- 3,275
- Total
- 3,275
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K000275
K-number listed on FDA's recall record- Z-0814-2025 — Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992
- Z-2161-2013 — Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K000275.
Data sourced from openFDA. This site is unofficial and independent of the FDA.