HALOTHANE VAPORIZER 950, ENFLURANE— 510(k) K841157

Substantially Equivalent

Siemens Elema AB

FDA 510(k) clearance K841157 for HALOTHANE VAPORIZER 950, ENFLURANE, Substantially Equivalent on 1984-06-07. Applicant: Siemens Elema AB.

Clearance details

Applicant: Siemens Elema AB
Product code: Code CAD
Advisory panel: Anesthesiology
Date received: 1984-03-19
Decision date: 1984-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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.