AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000— 510(k) K021175

Substantially Equivalent

Aerogen, Inc.

FDA 510(k) clearance K021175 for AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000, Substantially Equivalent on 2002-05-15. Applicant: Aerogen, Inc..

Clearance details

Applicant: Aerogen, Inc.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2002-04-12
Decision date: 2002-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, 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.