Cleared Traditional

HUMID-VENT FILTER PEDI

K952084 · Gibeck, Inc. · Anesthesiology
Jun 1995
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K952084 is an FDA 510(k) clearance for the HUMID-VENT FILTER PEDI, 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 June 12, 1995, 40 days after receiving the submission on May 3, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K952084 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 1995
Decision Date June 12, 1995
Days to Decision 40 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