LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001— 510(k) K984328

Name: FDA 510(k) clearance K984328
Creator: U.S. Food and Drug Administration
Published: 1999-05-21

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K984328 for LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001, Substantially Equivalent on 1999-05-21. 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: 1998-12-03
Decision date: 1999-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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