| Device Classification Name |
Calculator, Pulmonary Function Data
|
| 510(k) Number |
K851805 |
| Device Name |
LPA-3 PRINTER |
| Applicant |
| LIFE PRODUCTS, INC. |
| 2545 CENTRAL AVE. |
|
BOULDER,
CO
80301
|
|
| Applicant Contact |
DOUGLAS BARNES |
| Correspondent |
| LIFE PRODUCTS, INC. |
| 2545 CENTRAL AVE. |
|
BOULDER,
CO
80301
|
|
| Correspondent Contact |
DOUGLAS BARNES |
| Regulation Number | 868.1880 |
| Classification Product Code |
|
| Date Received | 04/30/1985 |
| Decision Date | 07/08/1985 |
| 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
|
|
|