OXYGEN CANNULA EAR WRAP (STYLE A)— 510(k) K863431

Substantially Equivalent

Salter Labs

FDA 510(k) clearance K863431 for OXYGEN CANNULA EAR WRAP (STYLE A), Substantially Equivalent on 1986-09-18. Applicant: Salter Labs.

Clearance details

Applicant: Salter Labs
Product code: Code CAT
Advisory panel: Anesthesiology
Date received: 1986-09-04
Decision date: 1986-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arvin, CA, US

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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, 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.