Cleared Traditional

VENTURI VENTILATOR

K982174 · Cardiopulmonary Corp. · Anesthesiology
Jun 1998
Decision
7d
Days
Class 2
Risk

About This 510(k) Submission

K982174 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 June 24, 1998, 7 days after receiving the submission on June 17, 1998. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K982174 FDA.gov
FDA Decision Cleared ST
Date Received June 17, 1998
Decision Date June 24, 1998
Days to Decision 7 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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