CYGNUS 12 LEAD ECG MODULE— 510(k) K072950

Substantially Equivalent

Cygnus, LLC

FDA 510(k) clearance K072950 for CYGNUS 12 LEAD ECG MODULE, Substantially Equivalent on 2008-08-22. Applicant: Cygnus, LLC. Device class: 2.

Clearance details

Applicant: Cygnus, LLC
Product code: Code KRE
Device class: Class 2
Regulation: 21 CFR 870.3640
Advisory panel: Cardiovascular
Date received: 2007-10-18
Decision date: 2008-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paterson, NJ, US

Download summary PDF View on FDA.gov ↗

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