Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K003565 |
Device Name |
HEARTSTREAM FR2 AED, MODEL M3860A,M3861A |
Applicant |
AGILENT TECHNOLOGIES, INC. |
2401 FOURTH AVE., SUITE 500 |
SEATTLE,
WA
98121
|
|
Applicant Contact |
GRETCHEN SOLBERG |
Correspondent |
AGILENT TECHNOLOGIES, INC. |
2401 FOURTH AVE., SUITE 500 |
SEATTLE,
WA
98121
|
|
Correspondent Contact |
GRETCHEN SOLBERG |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 11/20/2000 |
Decision Date | 12/20/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|