OTE BIOMEDICAL #1296 - 16 CHAN. RECORD— 510(k) K820779

Name: FDA 510(k) clearance K820779
Creator: U.S. Food and Drug Administration
Published: 1982-04-26

Substantially Equivalent

Del Mar Avionics

FDA 510(k) clearance K820779 for OTE BIOMEDICAL #1296 - 16 CHAN. RECORD, Substantially Equivalent on 1982-04-26. Applicant: Del Mar Avionics. Device class: 2.

Clearance details

Applicant: Del Mar Avionics
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 1982-03-23
Decision date: 1982-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.