DRAGER-VAPOR 2000— 510(k) K971923
Substantially EquivalentDraeger Medical, Inc.
FDA 510(k) clearance K971923 for DRAGER-VAPOR 2000, Substantially Equivalent on 1997-09-16. Applicant: Draeger Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Draeger Medical, 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
- Traditional
- Location
- Telford, PA, US
Recent devices under product code CAD
view allMore clearances from Draeger Medical, 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 K971923
K-number listed on FDA's recall record- Z-0933-2026 — Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.
- Z-0934-2026 — Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K971923.
Data sourced from openFDA. This site is unofficial and independent of the FDA.