The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Supermon Neonatal Non-invasive Blood Press. 7283.
| Device ID | K882955 |
| 510k Number | K882955 |
| Device Name: | SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | David Cromwick |
| Correspondent | David Cromwick 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 | 1988-07-14 |
| Decision Date | 1990-01-26 |