| Device Classification Name |
Calculator, Pulmonary Function Data
|
| 510(k) Number |
K893845 |
| Device Name |
PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM |
| Applicant |
| MEDICAL ASSOCIATED SERVICES, INC. |
| P.O. BOX 530 |
|
HATFIELD,
PA
19440
|
|
| Applicant Contact |
BOX 530 |
| Correspondent |
| MEDICAL ASSOCIATED SERVICES, INC. |
| P.O. BOX 530 |
|
HATFIELD,
PA
19440
|
|
| Correspondent Contact |
BOX 530 |
| Regulation Number | 868.1880 |
| Classification Product Code |
|
| Date Received | 05/25/1989 |
| Decision Date | 10/27/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|