THERA-MIST(TM) NEBULIZER, MODEL 30000— 510(k) K893942

Substantially Equivalent

Pegasus Research Corp.

FDA 510(k) clearance K893942 for THERA-MIST(TM) NEBULIZER, MODEL 30000, Substantially Equivalent on 1989-08-28. Applicant: Pegasus Research Corp..

Clearance details

Applicant: Pegasus Research Corp.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1989-05-31
Decision date: 1989-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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.