The following data is part of a premarket notification filed by B-k Medical A/s with the FDA for Ultrasound Scanner Mini Focus, Model 1402.
| Device ID | K043554 |
| 510k Number | K043554 |
| Device Name: | ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | B-K MEDICAL A/S MILEPARKEN 34 Herlev, DK Dk-2730 |
| Contact | Villy Braender |
| Correspondent | Villy Braender B-K MEDICAL A/S MILEPARKEN 34 Herlev, DK Dk-2730 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-01-14 |
| Summary: | summary |