Cleared Traditional

FR6000 FLOWMETER

K884973 · Key Instruments · Anesthesiology
Jan 1989
Decision
48d
Days
Class 1
Risk

About This 510(k) Submission

K884973 is an FDA 510(k) clearance for the FR6000 FLOWMETER, a Flowmeter, Tube, Thorpe, Back-pressure Compensated (Class I — General Controls, product code CAX), submitted by Key Instruments (Trevose, US). The FDA issued a Cleared decision on January 17, 1989, 48 days after receiving the submission on November 30, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2340.

Submission Details

510(k) Number K884973 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1988
Decision Date January 17, 1989
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

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