The following data is part of a premarket notification filed by Toyota Tsusho Corporation with the FDA for Unexef-38g Ultrasound System.
| Device ID | K131973 |
| 510k Number | K131973 |
| Device Name: | UNEXEF-38G ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TOYOTA TSUSHO CORPORATION 504 RITTIMAN RD. San Antonio, TX 78209 |
| Contact | Doug Blakely |
| Correspondent | Doug Blakely TOYOTA TSUSHO CORPORATION 504 RITTIMAN RD. San Antonio, TX 78209 |
| 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 | No |
| Combination Product | No |
| Date Received | 2013-06-28 |
| Decision Date | 2014-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04573349040069 | K131973 | 000 |