Cleared Traditional

DISPOSABLE RESPIRTORY KIT (MP-200)

K896885 · Medipart Jerry Alexander · Radiology
Feb 1990
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K896885 is an FDA 510(k) clearance for the DISPOSABLE RESPIRTORY KIT (MP-200), 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 26, 1990, 80 days after receiving the submission on December 8, 1989. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1390.

Submission Details

510(k) Number K896885 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1989
Decision Date February 26, 1990
Days to Decision 80 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