The following data is part of a premarket notification filed by Med-tek Corp. with the FDA for Blood Pressure Device, 400 Series.
| Device ID | K781906 |
| 510k Number | K781906 |
| Device Name: | BLOOD PRESSURE DEVICE, 400 SERIES |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MED-TEK CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-11-13 |
| Decision Date | 1978-11-16 |