Cleared Traditional

INFANT FLOW SYSTEM

K945740 · Hamilton Medical, Inc. · Anesthesiology
Mar 1995
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K945740 is an FDA 510(k) clearance for the INFANT FLOW SYSTEM, a Set, Tubing And Support, Ventilator (w Harness) (Class I — General Controls, product code BZO), submitted by Hamilton Medical, Inc. (Reno, US). The FDA issued a Cleared decision on March 23, 1995, 120 days after receiving the submission on November 23, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number K945740 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 1994
Decision Date March 23, 1995
Days to Decision 120 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

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