Cleared Traditional

XENON CIRCUIT

K914747 · Gibeck, Inc. · Radiology
Feb 1992
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K914747 is an FDA 510(k) clearance for the XENON CIRCUIT, a System, Rebreathing, Radionuclide (Class II — Special Controls, product code IYT), submitted by Gibeck, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 27, 1992, 128 days after receiving the submission on October 22, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1390.

Submission Details

510(k) Number K914747 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1991
Decision Date February 27, 1992
Days to Decision 128 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