| 510(k) Number |
K827818 |
| Device Name |
DOPPLER FLOW METER, LASER |
| Applicant |
| Atl Interspec Cardiology |
| 110 W. Butler Ave. |
|
Ambler,
PA
19002
|
|
| Correspondent |
| Atl Interspec Cardiology |
| 110 W. Butler Ave. |
|
Ambler,
PA
19002
|
|
| Date Received | 07/22/1982 |
| Decision Date | 08/20/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Radiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|