LIFE+CEL OR LIFECEL BATTERY


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K073716
Device Name LIFE+CEL OR LIFECEL BATTERY
Applicant
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
377 zane court
hillside village
elizabeth, 
CO 
80107

Applicant Contact alex henderson
Correspondent
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
377 zane court
hillside village
elizabeth, 
CO 
80107

Correspodent Contact alex henderson
Regulation Number 870.5310
Classification Product Code
MKJ  
Date Received 12/31/2007
Decision Date 04/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No