Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM— 510(k) K172457

Name: FDA 510(k) clearance K172457
Creator: U.S. Food and Drug Administration
Published: 2018-06-28

Substantially Equivalent

Deltex Medical Limited

FDA 510(k) clearance K172457 for Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM, Substantially Equivalent on 2018-06-28. Applicant: Deltex Medical Limited. Device class: 2.

Clearance details

Applicant: Deltex Medical Limited
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2017-08-14
Decision date: 2018-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chichester, GB

Download summary PDF View on FDA.gov ↗

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