Cleared Traditional

SERIES D FLOWMETER

K872718 · Puritan Bennett Corp. · Anesthesiology
Aug 1987
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K872718 is an FDA 510(k) clearance for the SERIES D FLOWMETER, a Flowmeter, Tube, Thorpe, Back-pressure Compensated (Class I — General Controls, product code CAX), submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on August 5, 1987, 26 days after receiving the submission on July 10, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2340.

Submission Details

510(k) Number K872718 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 1987
Decision Date August 05, 1987
Days to Decision 26 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