Entropy Module, E-ENTROPY-01— 510(k) K150298

Name: FDA 510(k) clearance K150298
Creator: U.S. Food and Drug Administration
Published: 2015-11-12

Substantially Equivalent

Ge Healthcare Filand OY

FDA 510(k) clearance K150298 for Entropy Module, E-ENTROPY-01, Substantially Equivalent on 2015-11-12. Applicant: Ge Healthcare Filand OY. Device class: 2.

Clearance details

Applicant: Ge Healthcare Filand OY
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2015-02-06
Decision date: 2015-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

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