NASAL ONE— 510(k) K852628

Substantially Equivalent

Ashai Co. , Ltd.

FDA 510(k) clearance K852628 for NASAL ONE, Substantially Equivalent on 1985-09-18. Applicant: Ashai Co. , Ltd..

Clearance details

Applicant: Ashai Co. , Ltd.
Product code: Code CAT
Advisory panel: Anesthesiology
Date received: 1985-06-20
Decision date: 1985-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Australia, AU

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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.