Cleared Traditional

MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133

K896124 · Medipart Jerry Alexander · Radiology
Jan 1990
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K896124 is an FDA 510(k) clearance for the MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133, a System, Rebreathing, Radionuclide (Class II — Special Controls, product code IYT), submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on January 22, 1990, 91 days after receiving the submission on October 23, 1989. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1390.

Submission Details

510(k) Number K896124 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1989
Decision Date January 22, 1990
Days to Decision 91 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