| Device Classification Name |
electrode, electrocardiograph
|
|---|
| 510(k) Number |
K982470 |
|---|
| Device Name |
ECG ELECTRODES APRON |
|---|
| Applicant |
| TAPUZ MEDICAL TECHNOLOGY LTD. |
| 117 AHUZAH ST. |
|
RA'ANANNA,
IL
43373
|
|
| Applicant Contact |
SHOSHANA FRIEDMAN |
| Correspondent |
| TAPUZ MEDICAL TECHNOLOGY LTD. |
| 117 AHUZAH ST. |
|
RA'ANANNA,
IL
43373
|
|
| Correspondent Contact |
SHOSHANA FRIEDMAN |
| Regulation Number | 870.2360
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/16/1998 |
|---|
| Decision Date | 10/14/1998 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Cardiovascular
|
|---|
| 510k Review Panel |
Cardiovascular
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|