Cleared Special

MODIFICATION OF VENTURI VENTILATOR

K990429 · Cardiopulmonary Corp. · Anesthesiology
Feb 1999
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K990429 is an FDA 510(k) clearance for the MODIFICATION OF 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 February 24, 1999, 13 days after receiving the submission on February 11, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K990429 FDA.gov
FDA Decision Cleared ST
Date Received February 11, 1999
Decision Date February 24, 1999
Days to Decision 13 days
Submission Type Special
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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