Cleared Traditional

CO Check Pro, CO Screen

K171129 · MD Diagnostics Limited · Anesthesiology
Mar 2018
Decision
319d
Days
Class 2
Risk

About This 510(k) Submission

K171129 is an FDA 510(k) clearance for the CO Check Pro, CO Screen, a Analyzer, Gas, Carbon-monoxide, Gaseous-phase (Class II — Special Controls, product code CCJ), submitted by MD Diagnostics Limited (Maidstone, GB). The FDA issued a Cleared decision on March 2, 2018, 319 days after receiving the submission on April 17, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1430.

Submission Details

510(k) Number K171129 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2017
Decision Date March 02, 2018
Days to Decision 319 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCJ — Analyzer, Gas, Carbon-monoxide, Gaseous-phase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1430