MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458— 510(k) K082011

Name: FDA 510(k) clearance K082011
Creator: U.S. Food and Drug Administration
Published: 2008-11-28

Substantially Equivalent

Bio-Medical Research, Ltd.

FDA 510(k) clearance K082011 for MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458, Substantially Equivalent on 2008-11-28. Applicant: Bio-Medical Research, Ltd.. Device class: 2.

Clearance details

Applicant: Bio-Medical Research, Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2008-07-15
Decision date: 2008-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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