Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K130454 |
Device Name |
LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR |
Applicant |
PHYSIO-CONTROL, INC. |
11811 WILLOWS ROAD NORTHEAST |
P.O. BOX 97006 |
REDMOND,
WA
98073 -9706
|
|
Applicant Contact |
MICHELLE ACKERMANN |
Correspondent |
PHYSIO-CONTROL, INC. |
11811 WILLOWS ROAD NORTHEAST |
P.O. BOX 97006 |
REDMOND,
WA
98073 -9706
|
|
Correspondent Contact |
MICHELLE ACKERMANN |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 02/22/2013 |
Decision Date | 08/21/2013 |
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
|
|
|