The following data is part of a premarket notification filed by B-k Medical A/s with the FDA for Ultrasound Scanner, Type 1101.
| Device ID | K023457 |
| 510k Number | K023457 |
| Device Name: | ULTRASOUND SCANNER, TYPE 1101 |
| Classification | System, Imaging, Pulsed Echo, 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 | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-15 |
| Decision Date | 2002-11-01 |
| Summary: | summary |