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 |