The following data is part of a premarket notification filed by Eastman Kodak Company with the FDA for Kodak Home Health Monitoring System.
| Device ID | K983928 |
| 510k Number | K983928 |
| Device Name: | KODAK HOME HEALTH MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -4757 |
| Contact | Judith A Wallace |
| Correspondent | Judith A Wallace EASTMAN KODAK COMPANY 901 ELMGROVE RD. Rochester, NY 14653 -4757 |
| Product Code | MWI |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DXN |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-05 |
| Decision Date | 2000-02-11 |