KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER


Device Classification Name

recorder, magnetic tape, medical

510(k) Number K111745
Device Name KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER
Applicant
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
555 zang street
suite 100
lakewood, 
CO 
80228

Applicant Contact clay anselmo
Correspondent
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
555 zang street
suite 100
lakewood, 
CO 
80228

Correspodent Contact clay anselmo
Regulation Number 870.2800
Classification Product Code
DSH  
Date Received 06/21/2011
Decision Date 08/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No