The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Nibp 9225 Combi.
| Device ID | K912815 |
| 510k Number | K912815 |
| Device Name: | NIBP 9225 COMBI |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Morten Nielson |
| Correspondent | Morten Nielson S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-06 |
| Decision Date | 1992-10-09 |