Cleared Traditional

EEE

K953540 · Edentec Corp. · Anesthesiology
Aug 1995
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K953540 is an FDA 510(k) clearance for the EEE, a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on August 25, 1995, 28 days after receiving the submission on July 28, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K953540 FDA.gov
FDA Decision Cleared SESE
Date Received July 28, 1995
Decision Date August 25, 1995
Days to Decision 28 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

Similar Devices — BYD Condenser, Heat And Moisture (artificial Nose)

All 72
HEAT & MOISTURE EXCHANGER
K955008 · Intertech Resources, Inc. · Jan 1996
DISPOSABLE HME/FILTER
K954194 · Engstrom Medical · Oct 1995
HEAT MOISTURE EXCHANGER
K953580 · Intertech Resources, Inc. · Sep 1995
TYPE 1 & 2 (HUMIDAIR I & II)
K953507 · Icor AB · Sep 1995
HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
K953491 · Gibeck, Inc. · Aug 1995
HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
K953544 · Gibeck, Inc. · Aug 1995