PHILIPS HEARTSTART SMARTPADS III


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K072812
Device Name PHILIPS HEARTSTART SMARTPADS III
Applicant
PHILIPS MEDICAL SYSTEMS
2301 fifth ave., suite 200
seattle, 
WA 
98121

Applicant Contact larry walker
Correspondent
PHILIPS MEDICAL SYSTEMS
2301 fifth ave., suite 200
seattle, 
WA 
98121

Correspodent Contact larry walker
Regulation Number 870.5310
Classification Product Code
MKJ  
Subsequent Product Code
MLN  
Date Received 10/01/2007
Decision Date 02/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No