The following data is part of a premarket notification filed by Teratech Corporation with the FDA for Terason Usmart 3200t Plus Ultrasound System.
| Device ID | K201633 |
| 510k Number | K201633 |
| Device Name: | Terason USmart 3200T Plus Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Teratech Corporation 77-79 Terrace Hall Ave. Burlington, MA 01803 |
| Contact | Benjamin Chiampa |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-06-16 |
| Decision Date | 2020-07-02 |