Cleared Traditional

AMICI XENON ADMINISTRATION SET

K903805 · Amici, Inc. · Radiology
Jan 1991
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K903805 is an FDA 510(k) clearance for the AMICI XENON ADMINISTRATION SET, a System, Rebreathing, Radionuclide (Class II — Special Controls, product code IYT), submitted by Amici, Inc. (Spring City, US). The FDA issued a Cleared decision on January 14, 1991, 152 days after receiving the submission on August 15, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1390.

Submission Details

510(k) Number K903805 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1990
Decision Date January 14, 1991
Days to Decision 152 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

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