CARDIOMD-AC— 510(k) K040616

Substantially Equivalent

Danish Diagnostic Development A/S

FDA 510(k) clearance K040616 for CARDIOMD-AC, Substantially Equivalent on 2004-03-24. Applicant: Danish Diagnostic Development A/S. Device class: 2.

Clearance details

Applicant: Danish Diagnostic Development A/S
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2004-03-09
Decision date: 2004-03-24
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Horsholm, DK

Download summary PDF View on FDA.gov ↗

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More clearances from Danish Diagnostic Development A/S

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K001888 — UNICORN MODEL SYS06302000-06-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.