Cleared Traditional

XENON CIRCUIT

K953513 · King Systems Corp. · Radiology
Nov 1995
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K953513 is an FDA 510(k) clearance for the XENON CIRCUIT, a System, Rebreathing, Radionuclide (Class II — Special Controls, product code IYT), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on November 3, 1995, 100 days after receiving the submission on July 26, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1390.

Submission Details

510(k) Number K953513 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1995
Decision Date November 03, 1995
Days to Decision 100 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IYT — System, Rebreathing, Radionuclide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1390

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