OTE BIOMEDICA BERG FOURIER ANALYZER— 510(k) K820653

Substantially Equivalent

Del Mar Avionics

FDA 510(k) clearance K820653 for OTE BIOMEDICA BERG FOURIER ANALYZER, Substantially Equivalent on 1982-05-07. Applicant: Del Mar Avionics.

Clearance details

Applicant
Del Mar Avionics
Product code
Code OLT
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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.