ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300— 510(k) K951259

Substantially Equivalent

Impulso Trading Co.

FDA 510(k) clearance K951259 for ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300, Substantially Equivalent on 1995-06-20. Applicant: Impulso Trading Co..

Clearance details

Applicant: Impulso Trading Co.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1995-03-21
Decision date: 1995-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, 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.