The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Pms 7000.
| Device ID | K812354 |
| 510k Number | K812354 |
| Device Name: | KONTRON PMS 7000 |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | KONTRON INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-19 |
| Decision Date | 1981-09-25 |