NEBULAIRE (IRC 1040) NEBULIZER PUMP— 510(k) K851436

Substantially Equivalent

Invacare Corp.

FDA 510(k) clearance K851436 for NEBULAIRE (IRC 1040) NEBULIZER PUMP, Substantially Equivalent on 1985-07-08. Applicant: Invacare Corp..

Clearance details

Applicant: Invacare Corp.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1985-04-10
Decision date: 1985-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, US

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.