Cleared Traditional

PRIMA, INC. VENTILATOR HOSES

K944532 · Prima, Inc. · Anesthesiology
Dec 1994
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K944532 is an FDA 510(k) clearance for the PRIMA, INC. VENTILATOR HOSES, a Connector, Airway (extension) (Class I — General Controls, product code BZA), 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 868.5810.

Submission Details

510(k) Number K944532 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 BZA — Connector, Airway (extension)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5810

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