The following data is part of a premarket notification filed by B-k Medical Aps with the FDA for Ultrasound Scanner Flex Focus.
| Device ID | K123254 |
| 510k Number | K123254 |
| Device Name: | ULTRASOUND SCANNER FLEX FOCUS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | B-K MEDICAL APS MILEPARKEN 34 Herlev, DK Dk-2730 |
| Contact | Randi Hauerberg |
| Correspondent | Randi Hauerberg B-K MEDICAL APS 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-18 |
| Decision Date | 2013-02-13 |
| Summary: | summary |