EEC-1 PACKAGE— 510(k) K923819

Substantially Equivalent

Med Labs, Inc.

FDA 510(k) clearance K923819 for EEC-1 PACKAGE, Substantially Equivalent on 1992-11-06. Applicant: Med Labs, Inc..

Clearance details

Applicant
Med Labs, Inc.
Product code
Code ILQ
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Goleta, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code ILQ

product code ILQ
Death
4
Malfunction
477
Total
481

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.