Cleared Traditional

VENTURI VENTILATOR

K943412 · Cardiopulmonary Corp. · Anesthesiology
Oct 1995
Decision
459d
Days
Class 2
Risk

About This 510(k) Submission

K943412 is an FDA 510(k) clearance for the VENTURI VENTILATOR, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Cardiopulmonary Corp. (Milford, US). The FDA issued a Cleared decision on October 16, 1995, 459 days after receiving the submission on July 14, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K943412 FDA.gov
FDA Decision Cleared ST
Date Received July 14, 1994
Decision Date October 16, 1995
Days to Decision 459 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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