| Device Classification Name |
nebulizer (direct patient interface)
|
|---|
| 510(k) Number |
K970344 |
|---|
| Device Name |
MDILOG, MODEL MDC-511 |
|---|
| Applicant |
| MEDTRAK TECHNOLOGIES, INC. |
| 12364 W. ALAMEDA PKWY. |
| SUITE 115 |
|
LAKEWOOD,
CO
80228
|
|
| Applicant Contact |
LINDA NELSON |
| Correspondent |
| MEDTRAK TECHNOLOGIES, INC. |
| 12364 W. ALAMEDA PKWY. |
| SUITE 115 |
|
LAKEWOOD,
CO
80228
|
|
| Correspondent Contact |
LINDA NELSON |
| Regulation Number | 868.5630
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 01/29/1997 |
|---|
| Decision Date | 08/06/1997 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Anesthesiology
|
|---|
| 510k Review Panel |
Anesthesiology
|
|---|
| Summary |
Summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|