LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000— 510(k) K061941

Name: FDA 510(k) clearance K061941
Creator: U.S. Food and Drug Administration
Published: 2006-08-21

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K061941 for LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000, Substantially Equivalent on 2006-08-21. Applicant: Elekta Instrument AB. Device class: 2.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 2006-07-10
Decision date: 2006-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

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