OSADA ENAC— 510(k) K844250

Substantially Equivalent

Osada Electric Co., Ltd.

FDA 510(k) clearance K844250 for OSADA ENAC, Substantially Equivalent on 1985-01-23. Applicant: Osada Electric Co., Ltd..

Clearance details

Applicant
Osada Electric Co., Ltd.
Product code
Code ELC
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Los Angeles, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ELC

product code ELC
Malfunction
1,255
Total
1,255

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.