DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES— 510(k) K013389

Name: FDA 510(k) clearance K013389
Creator: U.S. Food and Drug Administration
Published: 2002-01-10

Substantially Equivalent

Datex-Ohmeda

FDA 510(k) clearance K013389 for DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES, Substantially Equivalent on 2002-01-10. Applicant: Datex-Ohmeda. Device class: 2.

Clearance details

Applicant: Datex-Ohmeda
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2001-10-12
Decision date: 2002-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

Download summary PDF View on FDA.gov ↗

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