BIS INTERFACE FOR VITALOGIK PATIENT MONITORS— 510(k) K083063

Name: FDA 510(k) clearance K083063
Creator: U.S. Food and Drug Administration
Published: 2008-12-16

Substantially Equivalent

Mennen Medical , Ltd.

FDA 510(k) clearance K083063 for BIS INTERFACE FOR VITALOGIK PATIENT MONITORS, Substantially Equivalent on 2008-12-16. Applicant: Mennen Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Mennen Medical , Ltd.
Product code: Code OLW
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2008-10-14
Decision date: 2008-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rohovot, IL

Download summary PDF View on FDA.gov ↗

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