Cleared Traditional

CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004

K893760 · Nova-Ventrx · Anesthesiology
Aug 1989
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K893760 is an FDA 510(k) clearance for the CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004, 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 August 10, 1989, 83 days after receiving the submission on May 19, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number K893760 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 1989
Decision Date August 10, 1989
Days to Decision 83 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