| Device Classification Name |
Dc-Defibrillator, Low-Energy, (Including Paddles)
|
|---|
| 510(k) Number |
K971436 |
|---|
| Device Name |
NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES |
|---|
| Applicant |
| Nihon Kohden America, Inc. |
| 2601 Campus Dr. |
|
Irvine,
CA
92612
|
|
| Applicant Contact |
GARY REASONER |
| Correspondent |
| Nihon Kohden America, Inc. |
| 2601 Campus Dr. |
|
Irvine,
CA
92612
|
|
| Correspondent Contact |
GARY REASONER |
| Regulation Number | 870.5300 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/18/1997 |
|---|
| Decision Date | 10/21/1997 |
|---|
| Decision |
SE SUBJECT TO TRACKING REG
(ST) |
|---|
| Regulation Medical Specialty |
Cardiovascular
|
|---|
| 510k Review Panel |
Cardiovascular
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|