DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES— 510(k) K052145

Name: FDA 510(k) clearance K052145
Creator: U.S. Food and Drug Administration
Published: 2005-08-23

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K052145 for DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES, Substantially Equivalent on 2005-08-23. 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: 2005-08-08
Decision date: 2005-08-23
Decision: Substantially Equivalent
Clearance type: Special
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.