The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Sigma 1 Digital Echocardiograph System.
| Device ID | K875334 |
| 510k Number | K875334 |
| Device Name: | KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM |
| Classification | Transducer, Ultrasonic, Obstetric |
| 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 | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-30 |
| Decision Date | 1988-03-24 |