The following data is part of a premarket notification filed by Kontron Medical Systems Sas with the FDA for Sigma 110/330 Diagnostic Ultrasound System.
| Device ID | K002239 |
| 510k Number | K002239 |
| Device Name: | SIGMA 110/330 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | KONTRON MEDICAL SYSTEMS SAS 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07601 |
| Contact | George Myers |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-07-24 |
| Decision Date | 2000-08-08 |