The following data is part of a premarket notification filed by Bk Medical Aps with the FDA for Ultrasound Scanner System Bk2300.
| Device ID | K180737 |
| 510k Number | K180737 |
| Device Name: | Ultrasound Scanner System Bk2300 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BK Medical ApS Mileparken 34 Herlev, DK 2730 |
| Contact | Susana Mogensen |
| Correspondent | Susana Mogensen 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 | 2018-03-22 |
| Decision Date | 2018-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05704916001315 | K180737 | 000 |
| 05704916001131 | K180737 | 000 |
| 05704916000240 | K180737 | 000 |
| 05704916001599 | K180737 | 000 |
| 05704916001711 | K180737 | 000 |