Cleared Traditional

DISPOSABLE HME/FILTER

K954194 · Engstrom Medical · Anesthesiology
Oct 1995
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K954194 is an FDA 510(k) clearance for the DISPOSABLE HME/FILTER, a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by Engstrom Medical (Sturgis, US). The FDA issued a Cleared decision on October 20, 1995, 44 days after receiving the submission on September 6, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K954194 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1995
Decision Date October 20, 1995
Days to Decision 44 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BYD — Condenser, Heat And Moisture (artificial Nose)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5375