Cleared Traditional

CAPNOMASK

K131339 · Mediplus , Ltd. · Anesthesiology
Nov 2013
Decision
200d
Days
Class 2
Risk

About This 510(k) Submission

K131339 is an FDA 510(k) clearance for the CAPNOMASK, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Mediplus , Ltd. (Bonita Springs, US). The FDA issued a Cleared decision on November 25, 2013, 200 days after receiving the submission on May 9, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K131339 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 2013
Decision Date November 25, 2013
Days to Decision 200 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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