| Device Classification Name |
Meter, Peak Flow, Spirometry
|
| 510(k) Number |
K940836 |
| Device Name |
PEAKLOG AND DISPLAY SOFTWARE |
| Applicant |
| Tamarac Systems Corp. |
| 4890 Ironton St., Suite 6l |
|
Denver,
CO
80239
|
|
| Applicant Contact |
MARCIE CONNELLY |
| Correspondent |
| Tamarac Systems Corp. |
| 4890 Ironton St., Suite 6l |
|
Denver,
CO
80239
|
|
| Correspondent Contact |
MARCIE CONNELLY |
| Regulation Number | 868.1860 |
| Classification Product Code |
|
| Date Received | 02/23/1994 |
| Decision Date | 11/01/1994 |
| 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
|
|
|