| Device Classification Name |
Aid, Cardiopulmonary Resuscitation
|
| 510(k) Number |
K954692 |
| Device Name |
CPR PROMPT |
| Applicant |
| County Line , Ltd. |
| 4543 Taylor Ln. |
|
Warrensville,
OH
44128
|
|
| Applicant Contact |
TERRY G MAHN |
| Correspondent |
| County Line , Ltd. |
| 4543 Taylor Ln. |
|
Warrensville,
OH
44128
|
|
| Correspondent Contact |
TERRY G MAHN |
| Regulation Number | 870.5210 |
| Classification Product Code |
|
| Date Received | 10/11/1995 |
| Decision Date | 03/27/1996 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|