Cleared Traditional

MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT

K863756 · Nova-Ventrx · Anesthesiology

Nov 1986

Decision

49d

Days

Class 1

Risk

About This 510(k) Submission

K863756 is an FDA 510(k) clearance for the MODIFIED CRITERION VENTILATOR BREATHING 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 November 13, 1986, 49 days after receiving the submission on September 25, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number	K863756 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 25, 1986
Decision Date	November 13, 1986
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—