LEKSELL GAMMA UNIT MODEL 23004,TYPE B.— 510(k) K924849

Name: FDA 510(k) clearance K924849
Creator: U.S. Food and Drug Administration
Published: 1995-11-20

Substantially Equivalent

Elekta Radiosurgery, Inc.

FDA 510(k) clearance K924849 for LEKSELL GAMMA UNIT MODEL 23004,TYPE B., Substantially Equivalent on 1995-11-20. Applicant: Elekta Radiosurgery, Inc.. Device class: 2.

Clearance details

Applicant: Elekta Radiosurgery, Inc.
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 1992-09-28
Decision date: 1995-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

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