Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K022732 |
Device Name |
INFANT/CHILD REDUCED ENERGY ELECTRODES |
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 Code |
|
Date Received | 08/16/2002 |
Decision Date | 12/13/2002 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|