Cleared Special

SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES

K992503 · Sechrist Industries, Inc. · Anesthesiology
Aug 1999
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K992503 is an FDA 510(k) clearance for the SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on August 10, 1999, 14 days after receiving the submission on July 27, 1999. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K992503 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1999
Decision Date August 10, 1999
Days to Decision 14 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

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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