CANNULA, NASAL, FOR OXYGEN— 510(k) K760080

Substantially Equivalent

Inspiron Corp.

FDA 510(k) clearance K760080 for CANNULA, NASAL, FOR OXYGEN, Substantially Equivalent on 1976-07-15. Applicant: Inspiron Corp.. Device class: 1.

Clearance details

Applicant
Inspiron Corp.
Product code
Code CAT
Device class
Class 1
Regulation
21 CFR 868.5340
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CAT

product code CAT
Death
5
Malfunction
544
Other
2
Total
551

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.