MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES— 510(k) K061907

Name: FDA 510(k) clearance K061907
Creator: U.S. Food and Drug Administration
Published: 2008-03-27

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K061907 for MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES, Substantially Equivalent on 2008-03-27. Applicant: GE Healthcare. Device class: 2.

Clearance details

Applicant: GE Healthcare
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2006-07-05
Decision date: 2008-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, 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.