The following data is part of a premarket notification filed by Healcerion Co., Ltd with the FDA for Sonon Ultrasound Imaging System, Model: 300l.
| Device ID | K170085 |
| 510k Number | K170085 |
| Device Name: | SONON Ultrasound Imaging System, Model: 300L |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | HEALCERION CO., LTD 804HO, 38-21, DIGITAL-RO 31-GIL, GURO-GO Seoul, KR 08376 |
| Contact | Jaeyeob Jung |
| Correspondent | Carmelina G. Allis THE ALLIS LAW FIRM, PLLC 2437 BAY AREA BLVD., #30 Houston, TX 77058 |
| 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 | 2017-01-10 |
| Decision Date | 2017-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000879842 | K170085 | 000 |
| 00860000879835 | K170085 | 000 |
| 08809489920012 | K170085 | 000 |