Cleared Traditional

MaxCap Ped and MaxCap Neo

K182362 · Maxtec, LLC · Anesthesiology
May 2019
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K182362 is an FDA 510(k) clearance for the MaxCap Ped and MaxCap Neo, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Maxtec, LLC (Salt Lake City, US). The FDA issued a Cleared decision on May 23, 2019, 266 days after receiving the submission on August 30, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K182362 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2018
Decision Date May 23, 2019
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1400

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