STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE— 510(k) K827583

Name: FDA 510(k) clearance K827583
Creator: U.S. Food and Drug Administration
Published: 1982-09-29

Substantially Equivalent

Nucletronix, Inc.

FDA 510(k) clearance K827583 for STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE, Substantially Equivalent on 1982-09-29. Applicant: Nucletronix, Inc.. Device class: 2.

Clearance details

Applicant: Nucletronix, Inc.
Product code: Code IWB
Device class: Class 2
Regulation: 21 CFR 892.5750
Advisory panel: Radiology
Date received: 1982-08-30
Decision date: 1982-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gloucestor, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.