The following data is part of a premarket notification filed by Kontron Instruments, Inc. with the FDA for Kontron Sigma 44 Hvcd Ultrasound Imaging System.
| Device ID | K896437 |
| 510k Number | K896437 |
| Device Name: | KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM |
| Classification | Probe, Blood-flow, Extravascular |
| 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 | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-09 |
| Decision Date | 1990-12-03 |