SHOWER MINI RD-7 SANITARY WASHER— 510(k) K911551

Substantially Equivalent

Aiex USA , Ltd.

FDA 510(k) clearance K911551 for SHOWER MINI RD-7 SANITARY WASHER, Substantially Equivalent on 1991-09-06. Applicant: Aiex USA , Ltd..

Clearance details

Applicant
Aiex USA , Ltd.
Product code
Code ILJ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rancho Cucamonga, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ILJ

product code ILJ
Death
4
Total
4

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.