The following data is part of a premarket notification filed by Bk Medical Aps with the FDA for Ultrasound System 2300.
| Device ID | K222441 |
| 510k Number | K222441 |
| Device Name: | Ultrasound System 2300 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BK Medical Aps Mileparken 34 Herlev, DK 2730 |
| Contact | Sandra Theodoridis |
| Correspondent | Sandra Theodoridis BK Medical Aps Mileparken 34 Herlev, DK 2730 |
| 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 | 2022-08-12 |
| Decision Date | 2022-12-07 |