SOF-TOUCH NASAL CANNULA CAT.#304 & 305— 510(k) K802062

Substantially Equivalent

Hospitak, Inc.

FDA 510(k) clearance K802062 for SOF-TOUCH NASAL CANNULA CAT.#304 & 305, Substantially Equivalent on 1980-09-09. Applicant: Hospitak, Inc..

Clearance details

Applicant: Hospitak, Inc.
Product code: Code CAT
Advisory panel: Anesthesiology
Date received: 1980-08-27
Decision date: 1980-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.