Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K010918 |
Device Name |
LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM |
Applicant |
MEDTRONIC PHYSIO-CONTROL CORP. |
11811 WILLOWS RD., N.E. |
REDMOND,
WA
98073
|
|
Applicant Contact |
SHERRI L POCOCK |
Correspondent |
MEDTRONIC PHYSIO-CONTROL CORP. |
11811 WILLOWS RD., N.E. |
REDMOND,
WA
98073
|
|
Correspondent Contact |
SHERRI L POCOCK |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/27/2001 |
Decision Date | 08/23/2001 |
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
|
|
|