The following data is part of a premarket notification filed by S & W Medico Teknik with the FDA for Press 1 Press 2 9220 Updating Of The Module.
| Device ID | K912816 |
| 510k Number | K912816 |
| Device Name: | PRESS 1 PRESS 2 9220 UPDATING OF THE MODULE |
| Classification | Computer, Blood-pressure |
| Applicant | S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Contact | Lisbeth Isbrandt |
| Correspondent | Lisbeth Isbrandt S & W MEDICO TEKNIK HERSTEDVANG 8 DK-2620 ALBERTSLUND Denmark, DK |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-18 |
| Decision Date | 1992-04-10 |