Cleared Traditional

VOLUME VENTILATOR CIRCUIT W/WATER TRAP

K834570 · Airlife, Inc. · Anesthesiology
Mar 1984
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K834570 is an FDA 510(k) clearance for the VOLUME VENTILATOR CIRCUIT W/WATER TRAP, a Set, Tubing And Support, Ventilator (w Harness) (Class I — General Controls, product code BZO), submitted by Airlife, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984, 67 days after receiving the submission on December 29, 1983. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number K834570 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1983
Decision Date March 05, 1984
Days to Decision 67 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