Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K012428 |
Device Name |
MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR |
Applicant |
MEDTRONIC PHYSIO-CONTROL CORP. |
11811 WILLOWS RD NE |
P.O. BOX 97006 |
REDMOND,
WA
98073 -9706
|
|
Applicant Contact |
SHERRI L POCOCK |
Correspondent |
MEDTRONIC PHYSIO-CONTROL CORP. |
11811 WILLOWS RD NE |
P.O. BOX 97006 |
REDMOND,
WA
98073 -9706
|
|
Correspondent Contact |
SHERRI L POCOCK |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 07/31/2001 |
Decision Date | 09/28/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|