The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Supermon Non-invasive Blood Pressure Module 7282.
| Device ID | K861374 |
| 510k Number | K861374 |
| Device Name: | SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | George Cho |
| Correspondent | George Cho KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-11 |
| Decision Date | 1987-07-21 |