The following data is part of a premarket notification filed by Healcerion Co., Ltd with the FDA for Sonon Ultrasound Imaging System, Model: Sonon 500l.
| Device ID | K212400 |
| 510k Number | K212400 |
| Device Name: | SONON Ultrasound Imaging System, Model: SONON 500L |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Healcerion Co., Ltd 1403-ho, 12, Digital-ro 33-gil, Guro-gu Seoul, KR 08377 |
| Contact | Sooyeol Lee |
| Correspondent | Jong Hyun Kim GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Mapo-gu Seoul, KR 03909 |
| 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 | 2021-08-02 |
| Decision Date | 2022-04-22 |