LIFEPAK 12 BIPHASIC


Device Classification Name

automated external defibrillators (non-wearable)

510(k) Number K991910
Device Name LIFEPAK 12 BIPHASIC
Applicant
PHYSIO-CONTROL CORP.
11811 willows rd. n.e.
p.o. box 97006
redmond, 
WA 
98073 -9706

Applicant Contact michael d willingham
Correspondent
PHYSIO-CONTROL CORP.
11811 willows rd. n.e.
p.o. box 97006
redmond, 
WA 
98073 -9706

Correspodent Contact michael d willingham
Regulation Number 870.5310
Classification Product Code
MKJ  
Subsequent Product Codes
DQA   DRO   LDD  
Date Received 06/07/1999
Decision Date 09/03/1999
Decision

(ST)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls