| Device Classification Name |
Spirometer, Therapeutic (Incentive)
|
| 510(k) Number |
K944344 |
| Device Name |
LUNG TECHNOLOGIES 5000 THERAPEUTIC INCENTIVE SPIROMETER |
| Applicant |
| Lung Technologies, Inc. |
| 2620 186th Ave. NE |
|
Redmond,
WA
98052
|
|
| Applicant Contact |
KERRY M CURRAN |
| Correspondent |
| Lung Technologies, Inc. |
| 2620 186th Ave. NE |
|
Redmond,
WA
98052
|
|
| Correspondent Contact |
KERRY M CURRAN |
| Regulation Number | 868.5690 |
| Classification Product Code |
|
| Date Received | 09/06/1994 |
| Decision Date | 02/03/1995 |
| 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
|
|
|