Cleared Traditional

CO-AX VENTILATOR CIRCUIT

K850600 · Nova-Ventrx · Anesthesiology
May 1985
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K850600 is an FDA 510(k) clearance for the CO-AX VENTILATOR CIRCUIT, a Set, Tubing And Support, Ventilator (w Harness) (Class I — General Controls, product code BZO), submitted by Nova-Ventrx (Wheeling, US). The FDA issued a Cleared decision on May 2, 1985, 76 days after receiving the submission on February 15, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number K850600 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1985
Decision Date May 02, 1985
Days to Decision 76 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZO — Set, Tubing And Support, Ventilator (w Harness)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5975