| Device Classification Name |
Phonocardiograph
|
| 510(k) Number |
K902185 |
| Device Name |
DYNAMIC SPECTRAL PHONOCARDIOGRAPH |
| Applicant |
| Reeves Scientific, Inc. |
| 65 Nash St. |
|
New Haven,
CT
06511
|
|
| Applicant Contact |
WILLIAM REEVES |
| Correspondent |
| Reeves Scientific, Inc. |
| 65 Nash St. |
|
New Haven,
CT
06511
|
|
| Correspondent Contact |
WILLIAM REEVES |
| Regulation Number | 870.2390 |
| Classification Product Code |
|
| Date Received | 05/14/1990 |
| Decision Date | 03/25/1991 |
| 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
|
|
|