Cleared Traditional

K896125 - MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M
(FDA 510(k) Clearance)

K896125 · Medipart Jerry Alexander · Radiology

Feb 1990

Decision

101d

Days

Class 2

Risk

K896125 is an FDA 510(k) clearance for the MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133M, 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 February 1, 1990, 101 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	K896125 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 23, 1989
Decision Date	February 01, 1990
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—