| Device Classification Name |
Calculator, Pulmonary Function Data
|
| 510(k) Number |
K791503 |
| Device Name |
VITALOGRAPH FUNCTION ANALYZER |
| Applicant |
| Vitalograph , Ltd. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Vitalograph , Ltd. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 868.1880 |
| Classification Product Code |
|
| Date Received | 08/08/1979 |
| Decision Date | 08/16/1979 |
| 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
|
|
|