DG EXAMINER PLUS— 510(k) K953799

Substantially Equivalent

Medelec , Ltd.

FDA 510(k) clearance K953799 for DG EXAMINER PLUS, Substantially Equivalent on 1995-11-08. Applicant: Medelec , Ltd..

Clearance details

Applicant
Medelec , Ltd.
Product code
Code OLT
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Old Woking, Surrey, DE
Download summary PDFView on FDA.gov ↗

Adverse events under product code OLT

product code OLT
Other
1
Total
1

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.