Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+— 510(k) K150347

Name: FDA 510(k) clearance K150347
Creator: U.S. Food and Drug Administration
Published: 2015-07-24

Substantially Equivalent

Deltex Medical Limited

FDA 510(k) clearance K150347 for Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+, Substantially Equivalent on 2015-07-24. 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: 2015-02-11
Decision date: 2015-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chichester, GB

Download summary PDF View on FDA.gov ↗

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