510(k) K122857— HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100

Substantially Equivalent

Pegasus Research Corp.

Clearance details

Applicant: Pegasus Research Corp.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 2012-09-18
Decision date: 2012-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

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.