LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70— 510(k) K963924

Substantially Equivalent

Pari Holding Co.

FDA 510(k) clearance K963924 for LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70, Substantially Equivalent on 1996-12-10. Applicant: Pari Holding Co..

Clearance details

Applicant: Pari Holding Co.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1996-09-30
Decision date: 1996-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, VA, 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.