ENVOY PATIENT MONITOR— 510(k) K024245

Substantially Equivalent

Mennen Medical , Ltd.

FDA 510(k) clearance K024245 for ENVOY PATIENT MONITOR, Substantially Equivalent on 2004-05-10. Applicant: Mennen Medical , Ltd.. Device class: 2.

Clearance details

Applicant: Mennen Medical , Ltd.
Product code: Code OMC
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2002-12-23
Decision date: 2004-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rohovot, IL

Download summary PDF View on FDA.gov ↗

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