Cleared Traditional

CLEAN-AIR POLLUTION REDUCTION SYSTEM

K802067 · Porter Instrument Co., Inc. · Anesthesiology
Sep 1980
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K802067 is an FDA 510(k) clearance for the CLEAN-AIR POLLUTION REDUCTION SYSTEM, a Apparatus, Gas-scavenging (Class II — Special Controls, product code CBN), submitted by Porter Instrument Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980, 30 days after receiving the submission on August 27, 1980. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5430.

Submission Details

510(k) Number K802067 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1980
Decision Date September 26, 1980
Days to Decision 30 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBN — Apparatus, Gas-scavenging
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5430