Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K983393 |
Device Name |
LIFEPAK 500 BIPHASIC |
Applicant |
PHYSIO-CONTROL CORP. |
11811 WILLOWS RD. N.E. |
P.O. BOX 97006 |
REDMOND,
WA
98073 -9706
|
|
Applicant Contact |
SHERRI L POCOCK |
Correspondent |
PHYSIO-CONTROL CORP. |
11811 WILLOWS RD. N.E. |
P.O. BOX 97006 |
REDMOND,
WA
98073 -9706
|
|
Correspondent Contact |
SHERRI L POCOCK |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 09/25/1998 |
Decision Date | 05/05/1999 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|