The following data is part of a premarket notification filed by Bionet Co., Ltd. with the FDA for Sonome Wireless Probe Type Ultrasound Scanner (model: 5c, 5cb, H5c, 10l, 14l, 10lb, H10l, H5c10l) And Sonofinder Wireless Probe Type Ultrasound Scanner (model: Sf14l25).
| Device ID | K220169 |
| 510k Number | K220169 |
| Device Name: | SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) And SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Bionet Co., Ltd. 5F, 61 Digital-ro 31-gil Guro-gu Seoul, KR 08375 |
| Contact | ChuelWon Lee |
| Correspondent | ChuelWon Lee Bionet Co., Ltd. 5F, 61 Digital-ro 31-gil Guro-gu Seoul, KR 08375 |
| 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 | 2022-01-20 |
| Decision Date | 2022-10-11 |