Cleared Traditional

K934441 - KING SYSTEMS HME
(FDA 510(k) Clearance)

K934441 · King Systems Corp. · Anesthesiology
Dec 1993
Decision
83d
Days
Class 1
Risk

K934441 is an FDA 510(k) clearance for the KING SYSTEMS HME, a Condenser, Heat And Moisture (artificial Nose) (Class I — General Controls, product code BYD), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on December 2, 1993, 83 days after receiving the submission on September 10, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5375.

Submission Details

510(k) Number K934441 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 1993
Decision Date December 02, 1993
Days to Decision 83 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