Cleared Traditional

AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE

K903694 · Amici, Inc. · Radiology
Oct 1990
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K903694 is an FDA 510(k) clearance for the AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE, 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 October 3, 1990, 49 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 K903694 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 1990
Decision Date October 03, 1990
Days to Decision 49 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