Cleared Traditional

MATRX HOPE(R) 5 RESUSCITATOR

K921982 · Matrix Medica, Inc. · Anesthesiology
Oct 1994
Decision
913d
Days
Class 2
Risk

About This 510(k) Submission

K921982 is an FDA 510(k) clearance for the MATRX HOPE(R) 5 RESUSCITATOR, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on October 28, 1994, 913 days after receiving the submission on April 28, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K921982 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1992
Decision Date October 28, 1994
Days to Decision 913 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

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