Cleared Traditional

HEAT MOISTURE EXCHANGER

K953580 · Intertech Resources, Inc. · Anesthesiology
Sep 1995
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K953580 is an FDA 510(k) clearance for the HEAT MOISTURE EXCHANGER, a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on September 15, 1995, 45 days after receiving the submission on August 1, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K953580 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 1995
Decision Date September 15, 1995
Days to Decision 45 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