LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM— 510(k) K140680

Name: FDA 510(k) clearance K140680
Creator: U.S. Food and Drug Administration
Published: 2014-12-12

Substantially Equivalent

Alpine Biomed Aps

FDA 510(k) clearance K140680 for LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM, Substantially Equivalent on 2014-12-12. Applicant: Alpine Biomed Aps. Device class: 2.

Clearance details

Applicant: Alpine Biomed Aps
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2014-03-18
Decision date: 2014-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skovlunde, DK

Download summary PDF View on FDA.gov ↗

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