The following data is part of a premarket notification filed by Leltek Inc with the FDA for Leltek Ultrasound Imaging System (model: Lu700 Series).
| Device ID | K210432 |
| 510k Number | K210432 |
| Device Name: | LELTEK Ultrasound Imaging System (Model: LU700 Series) |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Leltek Inc 6F-3., No. 293, Sec. 1, Beixin Rd., Xindian Dist., New Taipei City, TW 23147 |
| Contact | Jessie Wang |
| Correspondent | Jessie Wang Leltek Inc 6F-3., No. 293, Sec. 1, Beixin Rd., Xindian Dist., New Taipei City, TW 23147 |
| 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 | 2021-02-12 |
| Decision Date | 2021-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008461223 | K210432 | 000 |
| 00860008461216 | K210432 | 000 |
| 00860008461209 | K210432 | 000 |
| 04719882150074 | K210432 | 000 |