DELTEX MEDICAL CARDIOQ-EDM+— 510(k) K132139

Name: FDA 510(k) clearance K132139
Creator: U.S. Food and Drug Administration
Published: 2013-10-10

Substantially Equivalent

Deltex Medical Limited

FDA 510(k) clearance K132139 for DELTEX MEDICAL CARDIOQ-EDM+, Substantially Equivalent on 2013-10-10. 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: 2013-07-11
Decision date: 2013-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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