| Device Classification Name |
Cable, Transducer And Electrode, Patient, (Including Connector)
|
| 510(k) Number |
K071751 |
| Device Name |
LIFESYNC ADAPTER, MODEL LS-302 |
| Applicant |
| Lifesync Corporation |
| 8282 Shadowwood Dr. |
|
Coral Springs,
FL
33071
|
|
| Applicant Contact |
DIANE SUDDUTH |
| Correspondent |
| Lifesync Corporation |
| 8282 Shadowwood Dr. |
|
Coral Springs,
FL
33071
|
|
| Correspondent Contact |
DIANE SUDDUTH |
| Regulation Number | 870.2900 |
| Classification Product Code |
|
| Date Received | 06/28/2007 |
| Decision Date | 08/27/2007 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Abbreviated
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|