| Device Classification Name |
Cpr Aid Device Without Feedback
|
| 510(k) Number |
K944667 |
| Device Name |
LIFE PULSE TESUSCITATION TIMER |
| Applicant |
| Green Field Medical Sourcing, Inc. |
| 910 Boston Tpke. Rd. |
|
Shrewsbury,
MA
01545
|
|
| Applicant Contact |
DONALD R GORSUCH |
| Correspondent |
| Green Field Medical Sourcing, Inc. |
| 910 Boston Tpke. Rd. |
|
Shrewsbury,
MA
01545
|
|
| Correspondent Contact |
DONALD R GORSUCH |
| Regulation Number | 870.5210 |
| Classification Product Code |
|
| Date Received | 09/20/1994 |
| Decision Date | 10/04/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Anesthesiology
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|