Cleared Traditional

SELECT FLOWMETER

K854067 · Precision Medical, Inc. · Anesthesiology
Oct 1985
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K854067 is an FDA 510(k) clearance for the SELECT FLOWMETER, a Flowmeter, Tube, Thorpe, Back-pressure Compensated (Class I — General Controls, product code CAX), submitted by Precision Medical, Inc. (Bath, US). The FDA issued a Cleared decision on October 29, 1985, 25 days after receiving the submission on October 4, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2340.

Submission Details

510(k) Number K854067 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 1985
Decision Date October 29, 1985
Days to Decision 25 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