DRAGER-VAPOR 2000— 510(k) K971923

Substantially Equivalent

Draeger Medical, Inc.

FDA 510(k) clearance K971923 for DRAGER-VAPOR 2000, Substantially Equivalent on 1997-09-16. Applicant: Draeger Medical, Inc..

Clearance details

Applicant: Draeger Medical, Inc.
Product code: Code CAD
Advisory panel: Anesthesiology
Date received: 1997-05-23
Decision date: 1997-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Telford, PA, US

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Adverse events under product code CAD

product code CAD

Malfunction: 3,275
Total: 3,275

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.