Cleared Traditional

SECHRIST INFANT VENTRILATOR MODEL IV-100

K811141 · Sechrist Industries, Inc. · Anesthesiology
Jun 1981
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K811141 is an FDA 510(k) clearance for the SECHRIST INFANT VENTRILATOR MODEL IV-100, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Sechrist Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981, 46 days after receiving the submission on April 27, 1981. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K811141 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1981
Decision Date June 12, 1981
Days to Decision 46 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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