System, Applicator, Radionuclide, Remote Controlled— 510(k) K170203

Name: FDA 510(k) clearance K170203
Creator: U.S. Food and Drug Administration
Published: 2017-06-01

Substantially Equivalent

Kobold, LLC

FDA 510(k) clearance K170203 for System, Applicator, Radionuclide, Remote Controlled, Substantially Equivalent on 2017-06-01. Applicant: Kobold, LLC. Device class: 2.

Clearance details

Applicant: Kobold, LLC
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2017-01-23
Decision date: 2017-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Liberty Lake, WA, US

Download summary PDF View on FDA.gov ↗

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