DEVICE FOR REPOSITIONING A BET PATIENT— 510(k) K813356

Substantially Equivalent

Ali-Oop Co., Inc.

FDA 510(k) clearance K813356 for DEVICE FOR REPOSITIONING A BET PATIENT, Substantially Equivalent on 1982-02-10. Applicant: Ali-Oop Co., Inc..

Clearance details

Applicant: Ali-Oop Co., Inc.
Product code: Code FNJ
Advisory panel: General Hospital
Date received: 1981-11-27
Decision date: 1982-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FNJ

product code FNJ

Death: 6
Total: 6

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.