Cleared Traditional

Maxtec MaxBlend2+p

K231895 · Maxtec, LLC · Anesthesiology
Dec 2023
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K231895 is an FDA 510(k) clearance for the Maxtec MaxBlend2+p, 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 December 4, 2023, 159 days after receiving the submission on June 28, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K231895 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2023
Decision Date December 04, 2023
Days to Decision 159 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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