Cleared Traditional

Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines

K151421 · Salter Labs · Anesthesiology
Mar 2016
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K151421 is an FDA 510(k) clearance for the Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Salter Labs (Carlsbad, US). The FDA issued a Cleared decision on March 10, 2016, 287 days after receiving the submission on May 28, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number K151421 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2015
Decision Date March 10, 2016
Days to Decision 287 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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