CYGNUS 12 LEAD ECG MODULE


Device Classification Name

analyzer, pacemaker generator function, indirect

510(k) Number K072950
Device Name CYGNUS 12 LEAD ECG MODULE
Applicant
CYGNUS, LLC
510 east 41st st.
paterson, 
NJ 
07504

Applicant Contact narcis naydenov
Correspondent
CYGNUS, LLC
510 east 41st st.
paterson, 
NJ 
07504

Correspodent Contact narcis naydenov
Regulation Number 870.3640
Classification Product Code
KRE  
Date Received 10/18/2007
Decision Date 08/22/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No