The following data is part of a premarket notification filed by Aguiflai Iberica S.l. with the FDA for Multifunction Keito.
| Device ID | K103058 |
| 510k Number | K103058 |
| Device Name: | MULTIFUNCTION KEITO |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | AGUIFLAI IBERICA S.L. LA PUJADA 19 Vilassar De Mar (barcelona), ES 08340 |
| Contact | Xavier Casals |
| Correspondent | Xavier Casals AGUIFLAI IBERICA S.L. LA PUJADA 19 Vilassar De Mar (barcelona), ES 08340 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-14 |
| Decision Date | 2011-11-10 |
| Summary: | summary |