Cleared Traditional

XENON GAS BREATHING CIRCUIT

K952223 · Intertech Resources, Inc. · Radiology
Aug 1995
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K952223 is an FDA 510(k) clearance for the XENON GAS BREATHING CIRCUIT, a System, Rebreathing, Radionuclide (Class II — Special Controls, product code IYT), submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on August 11, 1995, 91 days after receiving the submission on May 12, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1390.

Submission Details

510(k) Number K952223 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1995
Decision Date August 11, 1995
Days to Decision 91 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