Cleared Traditional

HEAT AND MOISTURE EXCHANGERS AND FILTERS

K941987 · Icor AB · Anesthesiology
Aug 1994
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K941987 is an FDA 510(k) clearance for the HEAT AND MOISTURE EXCHANGERS AND FILTERS, a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by Icor AB (Bromma, SE). The FDA issued a Cleared decision on August 15, 1994, 112 days after receiving the submission on April 25, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K941987 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1994
Decision Date August 15, 1994
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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