PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K111693
Device Name PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
Applicant
PHILIPS MEDICAL SYSTEMS
2301 5th avenue, suite 200
seattle, 
WA 
98121 -1825

Applicant Contact tamara yount
Correspondent
PHILIPS MEDICAL SYSTEMS
2301 5th avenue, suite 200
seattle, 
WA 
98121 -1825

Correspodent Contact tamara yount
Regulation Number 870.5310
Classification Product Code
MKJ  
Date Received 06/16/2011
Decision Date 10/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls