MODEL AFR EEG TELEPHONE RECEIVER— 510(k) K802657

Name: FDA 510(k) clearance K802657
Creator: U.S. Food and Drug Administration
Published: 1980-11-12

Substantially Equivalent

Telediagnostic Systems, Inc.

FDA 510(k) clearance K802657 for MODEL AFR EEG TELEPHONE RECEIVER, Substantially Equivalent on 1980-11-12. Applicant: Telediagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Telediagnostic Systems, Inc.
Product code: Code GYE
Device class: Class 2
Regulation: 21 CFR 882.1855
Advisory panel: Neurology
Date received: 1980-10-24
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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