The following data is part of a premarket notification filed by Healcerion Co., Ltd. with the FDA for Sonon Ultrasound Imaging System (model: Sonon 300c).
| Device ID | K151339 |
| 510k Number | K151339 |
| Device Name: | SONON Ultrasound Imaging System (Model: SONON 300C) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | HEALCERION CO., LTD. (GURO-DONG, CHANGUP JIWON CENTER), 72, DIGITAL-R0 26-GIL, GURO-GU Seoul, KR 151-848 |
| Contact | Jaeyeob Jung |
| Correspondent | Carmelina G Allis THE ALLIS LAW FIRM, PLLC 2437 BAY AREA BLVD., #30 Huston, TX 77058 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-19 |
| Decision Date | 2015-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000879811 | K151339 | 000 |
| 00860000879804 | K151339 | 000 |
| 08809489920005 | K151339 | 000 |