TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)— 510(k) K924194

Unknown

American Healthcare Corp.

FDA 510(k) clearance K924194 for TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686), Unknown on 1993-01-06. Applicant: American Healthcare Corp.. Device class: 2.

Clearance details

Applicant
American Healthcare Corp.
Product code
Code BTO
Device class
Class 2
Regulation
21 CFR 868.5800
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Unknown
Clearance type
Traditional
Location
South Plainfield, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BTO

product code BTO
Death
14
Injury
328
Malfunction
1,851
Total
2,193

Source: openFDA MAUDE database, through . 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.