The following data is part of a premarket notification filed by Leltek Inc with the FDA for Leltek Ultrasound Imaging System.
| Device ID | K191235 |
| 510k Number | K191235 |
| Device Name: | Leltek Ultrasound Imaging System |
| 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 | Kiefe Chang |
| Correspondent | Kiefe Chang 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 | 2019-05-08 |
| Decision Date | 2020-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719882150050 | K191235 | 000 |
| 04719882150043 | K191235 | 000 |
| 04719882151026 | K191235 | 000 |
| 04719882151019 | K191235 | 000 |
| 04719882150067 | K191235 | 000 |
| 00866955000492 | K191235 | 000 |
| 00866955000485 | K191235 | 000 |
| 04719882152061 | K191235 | 000 |
| 04719882152054 | K191235 | 000 |