Cleared Traditional

SECHRIST MODEL 990 JET VENTILATOR

K821930 · Sechrist Industries, Inc. · Anesthesiology
Aug 1982
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K821930 is an FDA 510(k) clearance for the SECHRIST MODEL 990 JET VENTILATOR, 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 August 16, 1982, 48 days after receiving the submission on June 29, 1982. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K821930 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1982
Decision Date August 16, 1982
Days to Decision 48 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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