MINI-CEARS COMPUTER (MODEL 1)— 510(k) K800001

Name: FDA 510(k) clearance K800001
Creator: U.S. Food and Drug Administration
Published: 1980-01-31

Substantially Equivalent

Bik Foundation, Inc.

FDA 510(k) clearance K800001 for MINI-CEARS COMPUTER (MODEL 1), Substantially Equivalent on 1980-01-31. Applicant: Bik Foundation, Inc.. Device class: 1.

Clearance details

Applicant: Bik Foundation, Inc.
Product code: Code GWS
Device class: Class 1
Regulation: 21 CFR 882.1420
Advisory panel: Neurology
Date received: 1980-01-02
Decision date: 1980-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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