Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K103567 |
Device Name |
LIFEPAK 15 MONITOR/DEFIBRILLATOR |
Applicant |
PHYSIO-CONTROL, INC. |
11811 WILLOWS RD., N.E. |
REDMOND,
WA
98052
|
|
Applicant Contact |
MICHELLE ACKERMANN |
Correspondent |
PHYSIO-CONTROL, INC. |
11811 WILLOWS RD., N.E. |
REDMOND,
WA
98052
|
|
Correspondent Contact |
MICHELLE ACKERMANN |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 12/06/2010 |
Decision Date | 03/22/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|