Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K003819 |
Device Name |
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A |
Applicant |
AGILENT TECHNOLOGIES, INC. |
2401 FOURTH AVE., SUITE 500 |
SEATTLE,
WA
98121
|
|
Applicant Contact |
TERESA SKARR |
Correspondent |
AGILENT TECHNOLOGIES, INC. |
2401 FOURTH AVE., SUITE 500 |
SEATTLE,
WA
98121
|
|
Correspondent Contact |
TERESA SKARR |
Regulation Number | 870.5310
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/11/2000 |
Decision Date | 05/02/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|