Cleared Traditional

MaxBlend 2, MaxBlend Lite

K161718 · Maxtec, LLC · Anesthesiology
Oct 2016
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K161718 is an FDA 510(k) clearance for the MaxBlend 2, MaxBlend Lite, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Maxtec, LLC (Salt Lake City, US). The FDA issued a Cleared decision on October 27, 2016, 127 days after receiving the submission on June 22, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K161718 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2016
Decision Date October 27, 2016
Days to Decision 127 days
Submission Type Traditional
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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