The following data is part of a premarket notification filed by Medtrak Technologies, Inc. with the FDA for Mdilog, Model Mdc-511.
| Device ID | K970344 |
| 510k Number | K970344 |
| Device Name: | MDILOG, MODEL MDC-511 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDTRAK TECHNOLOGIES, INC. 12364 W. ALAMEDA PKWY. SUITE 115 Lakewood, CO 80228 |
| Contact | Linda Nelson |
| Correspondent | Linda Nelson MEDTRAK TECHNOLOGIES, INC. 12364 W. ALAMEDA PKWY. SUITE 115 Lakewood, CO 80228 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-29 |
| Decision Date | 1997-08-06 |
| Summary: | summary |