The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Supermon Arrhythmia Module 7270.
| Device ID | K882206 |
| 510k Number | K882206 |
| Device Name: | SUPERMON ARRHYTHMIA MODULE 7270 |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-26 |
| Decision Date | 1989-04-05 |