| 510(k) Number |
K860555 |
| Device Name |
CPRCOACH VOICE PROMPTER & CPR PROMPTER RESCUE AID |
| Applicant |
| Auralogic |
| 111 Westport Ave. |
|
Norwalk,
CT
06851
|
|
| Applicant Contact |
HAROLD M STILLMAN |
| Correspondent |
| Auralogic |
| 111 Westport Ave. |
|
Norwalk,
CT
06851
|
|
| Correspondent Contact |
HAROLD M STILLMAN |
| Date Received | 02/14/1986 |
| Decision Date | 02/21/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|