The following data is part of a premarket notification filed by B-k Medical Aps with the FDA for Ultrasound Scanner Profocus, Model 2202.
| Device ID | K070077 |
| 510k Number | K070077 |
| Device Name: | ULTRASOUND SCANNER PROFOCUS, MODEL 2202 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | B-K MEDICAL APS MILEPARKEN 34 Herlev, DK Dk-2730 |
| Contact | Villy Braender |
| Correspondent | Villy Braender B-K MEDICAL APS MILEPARKEN 34 Herlev, DK Dk-2730 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-08 |
| Decision Date | 2007-03-05 |
| Summary: | summary |