Cleared Traditional

HEAT & MOISTURE EXCHANGER

K955008 · Intertech Resources, Inc. · Anesthesiology
Jan 1996
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K955008 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 January 30, 1996, 90 days after receiving the submission on November 1, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K955008 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 1995
Decision Date January 30, 1996
Days to Decision 90 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