Cleared Traditional

NITRONOX(R), FIRST RESPONSE NITRONOX(TM)

K883833 · Matrix Medica, Inc. · Anesthesiology
Feb 1989
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K883833 is an FDA 510(k) clearance for the NITRONOX(R), FIRST RESPONSE NITRONOX(TM), a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Matrix Medica, Inc. (Orchard Park, US). The FDA issued a Cleared decision on February 17, 1989, 161 days after receiving the submission on September 9, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K883833 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1988
Decision Date February 17, 1989
Days to Decision 161 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BZR — Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5330

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