Device Classification Name |
automated external defibrillators (non-wearable)
|
510(k) Number |
K042404 |
Device Name |
LIFEPAK, MODEL 1000 |
Applicant |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
11811 WILLOWS RD., N.E. |
PO BOX 97006 |
REDMOND,
WA
98073
|
|
Applicant Contact |
SHERRI POCOCK |
Correspondent |
MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. |
11811 WILLOWS RD., N.E. |
PO BOX 97006 |
REDMOND,
WA
98073
|
|
Correspondent Contact |
SHERRI POCOCK |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 09/03/2004 |
Decision Date | 12/22/2005 |
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
|
|
|