| Device Classification Name |
automated external defibrillators (non-wearable)
|
|---|
| 510(K) Number |
K120350 |
|---|
| Model |
THIS IS FOR THE RE-CELL OF ORIGINAL BATTERY PACKS
|
| Device Name |
EXTENDED LIFE BATTERY |
|---|
| Applicant |
| AED BATTERY EXCHANGE, LLC |
| 1000 brown street |
| suite 310 |
|
wauconda,
IL
60084
|
|
| Contact |
keith hochhalter |
| Regulation Number | 870.5310
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 02/06/2012 |
|---|
| Decision Date | 11/01/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Cardiovascular
|
|---|
| Review Advisory Committee |
Cardiovascular
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
