510(k) K924193— TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)

Unknown

American Healthcare Corp.

Clearance details

Applicant: American Healthcare Corp.
Product code: Code BTO
Advisory panel: Anesthesiology
Date received: 1992-08-20
Decision date: 1993-06-16
Decision: Unknown
Clearance type: Traditional
Location: South Plainfield, NJ, US

Adverse events under product code BTO

product code BTO

Death: 14
Injury: 328
Malfunction: 1,851
Total: 2,193

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.