CO Check Pro, CO Screen

FDA 510(k) K171129 · MD Diagnostics Limited

Substantially Equivalent

510(k) numberK171129

Submission

Device name
CO Check Pro, CO Screen
Applicant
MD Diagnostics Limited
Maidstone, GB
Received
April 17, 2017
Decision date
March 2, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1430
Specialty
Anesthesiology

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Questions and answers

When was CO Check Pro, CO Screen cleared by the FDA?

CO Check Pro, CO Screen (K171129) received a 510(k) decision of Substantially Equivalent on March 2, 2018, 319 days after the submission was received.

What is the product code of K171129?

The FDA product code is CCJ – Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1430.