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 |