OHIO DISPOSABLE TRACHEAL TUBE— 510(k) K810763

Substantially Equivalent

Airco/Ohio Medical Products

FDA 510(k) clearance K810763 for OHIO DISPOSABLE TRACHEAL TUBE, Substantially Equivalent on 1981-03-27. Applicant: Airco/Ohio Medical Products.

Clearance details

Applicant
Airco/Ohio Medical Products
Product code
Code BTR
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code BTR

product code BTR
Death
92
Injury
1,263
Malfunction
7,475
Other
2
Total
8,832

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.