Cleared Traditional

BMD AIR/OXYGEN BLENDER

K925982 · Biomedical Devices, Inc. · Anesthesiology
Oct 1993
Decision
316d
Days
Class 2
Risk

About This 510(k) Submission

K925982 is an FDA 510(k) clearance for the BMD AIR/OXYGEN BLENDER, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Biomedical Devices, Inc. (Madison, US). The FDA issued a Cleared decision on October 7, 1993, 316 days after receiving the submission on November 25, 1992. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K925982 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 1992
Decision Date October 07, 1993
Days to Decision 316 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

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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