LEKSELL GAMMAPLAN (LGP)— 510(k) K914808

Name: FDA 510(k) clearance K914808
Creator: U.S. Food and Drug Administration
Published: 1992-01-23

Substantially Equivalent

Elekta Instruments, Inc.

FDA 510(k) clearance K914808 for LEKSELL GAMMAPLAN (LGP), Substantially Equivalent on 1992-01-23. Applicant: Elekta Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Elekta Instruments, Inc.
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 1991-10-25
Decision date: 1992-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucker, GA, US

Download summary PDF View on FDA.gov ↗

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