Cleared Traditional

TRUZONE PFM DISPOSABLE MOUTHPIECE

K944512 · Monaghan Medical Corp. · Anesthesiology
Nov 1994
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K944512 is an FDA 510(k) clearance for the TRUZONE PFM DISPOSABLE MOUTHPIECE, a Mouthpiece, Breathing (Class I — General Controls, product code BYP), submitted by Monaghan Medical Corp. (Plattsburgh, US). The FDA issued a Cleared decision on November 2, 1994, 48 days after receiving the submission on September 15, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5620.

Submission Details

510(k) Number K944512 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1994
Decision Date November 02, 1994
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYP — Mouthpiece, Breathing
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5620