C-ERA-100 COMPUTERIZED ELECTRIC RESPON— 510(k) K792085

Name: FDA 510(k) clearance K792085
Creator: U.S. Food and Drug Administration
Published: 1979-10-30

Substantially Equivalent

Micro-Shev , Ltd.

FDA 510(k) clearance K792085 for C-ERA-100 COMPUTERIZED ELECTRIC RESPON, Substantially Equivalent on 1979-10-30. Applicant: Micro-Shev , Ltd.. Device class: 2.

Clearance details

Applicant: Micro-Shev , Ltd.
Product code: Code GWJ
Device class: Class 2
Regulation: 21 CFR 882.1900
Advisory panel: Neurology
Date received: 1979-10-17
Decision date: 1979-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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