Home / 510(k) Clearances / K072950

510(k) K072950

CYGNUS 12 LEAD ECG MODULE by Cygnus, LLC — Product Code KRE

K072950 is an FDA 510(k) premarket notification submitted by Cygnus, LLC for the device "CYGNUS 12 LEAD ECG MODULE". The FDA issued a decision of Substantially Equivalent on August 22, 2008. The device falls under product code KRE (Analyzer, Pacemaker Generator Function, Indirect), a Class II device regulated under 21 CFR 870.3640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2008
Date Received
October 18, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Pacemaker Generator Function, Indirect
Device Class
Class II
Regulation Number
870.3640
Review Panel
CV
Submission Type

Other clearances for product code KRE

  • K110693 — PACEART OPTIMA SYSTEM SOFTWARE (June 8, 2011)
  • K032926 — EKG SPEAKS (October 15, 2003)
  • K922742 — HPM 40 HEART PACEMAKER MONITOR (March 18, 1993)
  • K915632 — PACEART CPTS-86/12 (April 14, 1992)
  • K895535 — PACEVIEW (March 19, 1990)
  • K870909 — PACEMAKER FUNCTION ANALYZER (April 27, 1987)
  • K833647 — PACEMAKER SYS ANALYZER #384 (December 16, 1983)
  • K832959 — PACEMAKER SYS. ANALYZER 378 (November 14, 1983)
  • K803286 — CARDIOMEMO (March 17, 1981)
  • K800696 — ELECTRONIC PACEMAKER WAVEFORM ANALYZER (August 14, 1980)

FDA data resources