Cleared Traditional

OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067

K992670 · Instrumentation Industries, Inc. · Anesthesiology
Sep 1999
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K992670 is an FDA 510(k) clearance for the OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on September 17, 1999, 88 days after receiving the submission on June 21, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K992670 FDA.gov
FDA Decision Cleared ST
Date Received June 21, 1999
Decision Date September 17, 1999
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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