THE LUOMANEN ORAL AIRWAY— 510(k) K810123

Substantially Equivalent

Luomanen Medical Products

FDA 510(k) clearance K810123 for THE LUOMANEN ORAL AIRWAY, Substantially Equivalent on 1981-02-26. Applicant: Luomanen Medical Products.

Clearance details

Applicant
Luomanen Medical Products
Product code
Code CAE
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 CAE

product code CAE
Death
4
Total
4

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.