Cleared Traditional

K896475 - DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD
(FDA 510(k) Clearance)

K896475 · Medipart Jerry Alexander · Radiology
Jan 1990
Decision
70d
Days
Class 2
Risk

K896475 is an FDA 510(k) clearance for the DISP. RADIOAEROSOL KIT (MP-400) TO FIT LEAD SHIELD, 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, 70 days after receiving the submission on November 13, 1989. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1390.

Submission Details

510(k) Number K896475 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1989
Decision Date January 22, 1990
Days to Decision 70 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