The following data is part of a premarket notification filed by Bumedco Intl., Inc. with the FDA for Multifunction Keito K5.
| Device ID | K984083 |
| 510k Number | K984083 |
| Device Name: | MULTIFUNCTION KEITO K5 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | BUMEDCO INTL., INC. 725 TIMBER LN. Shoreview, MN 55126 |
| Contact | Darrold Glanville |
| Correspondent | Darrold Glanville BUMEDCO INTL., INC. 725 TIMBER LN. Shoreview, MN 55126 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-16 |
| Decision Date | 2000-01-18 |
| Summary: | summary |