Cleared Traditional

MXR-2000 FLOWMETER

K923781 · Porter Instrument Co., Inc. · Anesthesiology
Jun 1993
Decision
317d
Days
Class 1
Risk

About This 510(k) Submission

K923781 is an FDA 510(k) clearance for the MXR-2000 FLOWMETER, a Flowmeter, Tube, Thorpe, Back-pressure Compensated (Class I — General Controls, product code CAX), submitted by Porter Instrument Co., Inc. (Washington, US). The FDA issued a Cleared decision on June 10, 1993, 317 days after receiving the submission on July 28, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2340.

Submission Details

510(k) Number K923781 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1992
Decision Date June 10, 1993
Days to Decision 317 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAX — Flowmeter, Tube, Thorpe, Back-pressure Compensated
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.2340