The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Sigma 1sc Digital Echocardiography System.
| Device ID | K862686 |
| 510k Number | K862686 |
| Device Name: | KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-15 |
| Decision Date | 1987-02-27 |