Cleared Traditional

PRIMA, INC. CORRUGATED TUBING

K944531 · Prima, Inc. · Anesthesiology
Dec 1994
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K944531 is an FDA 510(k) clearance for the PRIMA, INC. CORRUGATED TUBING, a Set, Tubing And Support, Ventilator (w Harness) (Class I — General Controls, product code BZO), submitted by Prima, Inc. (Cleveland, US). The FDA issued a Cleared decision on December 2, 1994, 78 days after receiving the submission on September 15, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5975.

Submission Details

510(k) Number K944531 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1994
Decision Date December 02, 1994
Days to Decision 78 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