SYSTEM-ARMS, MODELS 390, X60— 510(k) K083164

Name: FDA 510(k) clearance K083164
Creator: U.S. Food and Drug Administration
Published: 2008-12-16

Substantially Equivalent

Bio-Medical Research, Ltd.

FDA 510(k) clearance K083164 for SYSTEM-ARMS, MODELS 390, X60, Substantially Equivalent on 2008-12-16. Applicant: Bio-Medical Research, Ltd.. Device class: 2.

Clearance details

Applicant: Bio-Medical Research, Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2008-10-27
Decision date: 2008-12-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

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