Cleared Traditional

POSITIVE AIRWAY PRESSURE SYSTEM

K933184 · Innovative Medical Systems, Inc. · Anesthesiology
Nov 1994
Decision
516d
Days
Class 2
Risk

About This 510(k) Submission

K933184 is an FDA 510(k) clearance for the POSITIVE AIRWAY PRESSURE SYSTEM, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Innovative Medical Systems, Inc. (Hampton, US). The FDA issued a Cleared decision on November 28, 1994, 516 days after receiving the submission on June 30, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K933184 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1993
Decision Date November 28, 1994
Days to Decision 516 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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