LIFEPAK 20E


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K073089
Device Name LIFEPAK 20E
Applicant
PHYSIO-CONTROL, INC.
11811 willows rd., n.e.
po box 97006
redmond, 
WA 
98052

Applicant Contact michelle ackermann
Correspondent
PHYSIO-CONTROL, INC.
11811 willows rd., n.e.
po box 97006
redmond, 
WA 
98052

Correspodent Contact michelle ackermann
Regulation Number 870.5310
Classification Product Code
MKJ  
Date Received 11/01/2007
Decision Date 07/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls