Cleared Traditional

HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT

K953544 · Gibeck, Inc. · Anesthesiology
Aug 1995
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K953544 is an FDA 510(k) clearance for the HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT, a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by Gibeck, Inc. (Indianapolis, 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 K953544 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