The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Stressdata Stress Data Management System.
| Device ID | K870816 |
| 510k Number | K870816 |
| Device Name: | KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | KONTRON INSTRUMENTS, INC. 9 PLYMOUTH ST. Everett, MA 02149 |
| Contact | Ellen F Benedict |
| Correspondent | Ellen F Benedict 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 | 1987-03-03 |
| Decision Date | 1988-03-01 |