Cleared Traditional

KAB SYSTEM

K951093 · King Systems Corp. · Anesthesiology
Mar 1995
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K951093 is an FDA 510(k) clearance for the KAB SYSTEM, a Absorber, Carbon-dioxide (Class I — General Controls, product code BSF), submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on March 24, 1995, 15 days after receiving the submission on March 9, 1995. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5310.

Submission Details

510(k) Number K951093 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1995
Decision Date March 24, 1995
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BSF — Absorber, Carbon-dioxide
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5310

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