K031686

Substantially Equivalent

AEROMIST LT, MODEL HCS15004

Applicant: Medline Industries, Inc.
Product code: BTI
Advisory panel: Anesthesiology
Date received: 2003-06-02
Decision date: 2004-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mundelein, IL, US

Adverse events under product code BTI

product code BTI

Death: 25
Malfunction: 1,168
Total: 1,193

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.