THERA-MIST NEBULIZER MODEL-P3000— 510(k) K962534

Substantially Equivalent

Pegasus Research Corp.

FDA 510(k) clearance K962534 for THERA-MIST NEBULIZER MODEL-P3000, Substantially Equivalent on 1997-02-28. Applicant: Pegasus Research Corp..

Clearance details

Applicant: Pegasus Research Corp.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1996-06-28
Decision date: 1997-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, 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.