Cleared Traditional

K833982 - MODEL IV 100B-DA INFANT VENTILATOR
(FDA 510(k) Clearance)

K833982 · Sechrist Industries, Inc. · Anesthesiology
Mar 1984
Decision
109d
Days
Class 2
Risk

K833982 is an FDA 510(k) clearance for the MODEL IV 100B-DA INFANT VENTILATOR, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Sechrist Industries, Inc. (Walker, US). The FDA issued a Cleared decision on March 5, 1984, 109 days after receiving the submission on November 17, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K833982 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1983
Decision Date March 05, 1984
Days to Decision 109 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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