Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K002445 |
Device Name |
LIFEPAK 12DEFIBERLLATOR/MONITOR SERIES |
Applicant |
MEDTRONIC PHYSIO-CONTROL CORP. |
11811 WILLOWS RD., N.E. |
REDMOND,
WA
98073
|
|
Applicant Contact |
BOB ZITO |
Correspondent |
MEDTRONIC PHYSIO-CONTROL CORP. |
11811 WILLOWS RD., N.E. |
REDMOND,
WA
98073
|
|
Correspondent Contact |
BOB ZITO |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/09/2000 |
Decision Date | 01/31/2001 |
Decision |
SE SUBJECT TO TRACKING REG
(ST) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|