Cleared Traditional

WARM N WET HME W/LUER ADAPTER

K953619 · Hospitak, Inc. · Anesthesiology
Aug 1995
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K953619 is an FDA 510(k) clearance for the WARM N WET HME W/LUER ADAPTER, a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by Hospitak, Inc. (Farmingdale, US). The FDA issued a Cleared decision on August 25, 1995, 22 days after receiving the submission on August 3, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K953619 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1995
Decision Date August 25, 1995
Days to Decision 22 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