Device Classification Name |
Automated External Defibrillators (Non-Wearable)
|
510(k) Number |
K082861 |
Device Name |
AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561 |
Applicant |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
377 ZANE COURT |
ELIZABETH,
CO
80107
|
|
Applicant Contact |
ALEXANDER B HENDERSON SR. |
Correspondent |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
377 ZANE COURT |
ELIZABETH,
CO
80107
|
|
Correspondent Contact |
ALEXANDER B HENDERSON SR. |
Regulation Number | 870.5310
|
Classification Product Code |
|
Date Received | 09/29/2008 |
Decision Date | 11/25/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|