CARDIOMED


Device Classification Name

dc-defibrillator, low-energy, (including paddles)

510(k) Number K103651
Device Name CARDIOMED
Applicant
CARDIO MEDICAL PRODUCTS, INC.
385 franklin ave. ste. l
rockaway, 
NJ 
07866

Applicant Contact nick mendise
Correspondent
CARDIO MEDICAL PRODUCTS, INC.
385 franklin ave. ste. l
rockaway, 
NJ 
07866

Correspodent Contact nick mendise
Regulation Number 870.5300
Classification Product Code
LDD  
Date Received 12/14/2010
Decision Date 10/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No