ASTHMAKIT— 510(k) K874047

Substantially Equivalent

Dhd Medical Products Div. Diemolding Corp.

FDA 510(k) clearance K874047 for ASTHMAKIT, Substantially Equivalent on 1988-02-29. Applicant: Dhd Medical Products Div. Diemolding Corp..

Clearance details

Applicant: Dhd Medical Products Div. Diemolding Corp.
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1987-10-05
Decision date: 1988-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canastota, NY, 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.