The following data is part of a premarket notification filed by Esaote Biomedica Elettronica with the FDA for Sim 4000i Ultrasound System-transducer For Sm 24/4.
| Device ID | K890963 |
| 510k Number | K890963 |
| Device Name: | SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ESAOTE BIOMEDICA ELETTRONICA ONE ALEWIFE PLACE Cambridge, MA 02140 |
| Contact | Sayigh, Phd |
| Correspondent | Sayigh, Phd ESAOTE BIOMEDICA ELETTRONICA ONE ALEWIFE PLACE Cambridge, MA 02140 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-27 |
| Decision Date | 1989-07-19 |