CO Check Pro, CO Screen— 510(k) K171129

Substantially Equivalent

MD Diagnostics Limited

FDA 510(k) clearance K171129 for CO Check Pro, CO Screen, Substantially Equivalent on 2018-03-02. Applicant: MD Diagnostics Limited. Device class: 2.

Clearance details

Applicant: MD Diagnostics Limited
Product code: Code CCJ
Device class: Class 2
Regulation: 21 CFR 868.1430
Advisory panel: Anesthesiology
Date received: 2017-04-17
Decision date: 2018-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maidstone, GB

Download summary PDF View on FDA.gov ↗

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