The following data is part of a premarket notification filed by B-k Medical A/s with the FDA for Ultrasound Scanner Type 2101.
| Device ID | K003041 |
| 510k Number | K003041 |
| Device Name: | ULTRASOUND SCANNER TYPE 2101 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | B-K MEDICAL A/S SANDTOFTEN 9 Gentofte, DK Dk-2820 |
| Contact | Villy Braender |
| Correspondent | Villy Braender B-K MEDICAL A/S SANDTOFTEN 9 Gentofte, DK Dk-2820 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-29 |
| Decision Date | 2001-02-07 |