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 | K002085 |
| 510k Number | K002085 |
| Device Name: | ULTRASOUND SCANNER, TYPE 1101 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | B & K MEDICAL A/S SANDTOFTEN 9 Dk 2820 Gentofte, DK |
| Contact | Villy Braender |
| Correspondent | Villy Braender B & K MEDICAL A/S SANDTOFTEN 9 Dk 2820 Gentofte, DK |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-10 |
| Decision Date | 2000-08-01 |