The following data is part of a premarket notification filed by B-k Medical Aps with the FDA for Ultrasound Scanner System Bk2300.
| Device ID | K140428 |
| 510k Number | K140428 |
| Device Name: | ULTRASOUND SCANNER SYSTEM BK2300 |
| Classification | System, Imaging, Pulsed Echo, 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 | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-19 |
| Decision Date | 2014-05-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05704916000257 | K140428 | 000 |
| 05704916000103 | K140428 | 000 |
| 05704916000097 | K140428 | 000 |
| 05704916000080 | K140428 | 000 |
| 05704916000066 | K140428 | 000 |
| 05704916000059 | K140428 | 000 |
| 05704916000042 | K140428 | 000 |
| 05704916000035 | K140428 | 000 |
| 05704916000028 | K140428 | 000 |
| 05704916000110 | K140428 | 000 |
| 05704916000127 | K140428 | 000 |
| 05704916000233 | K140428 | 000 |
| 05704916000226 | K140428 | 000 |
| 05704916000219 | K140428 | 000 |
| 05704916000202 | K140428 | 000 |
| 05704916000196 | K140428 | 000 |
| 05704916000172 | K140428 | 000 |
| 05704916000165 | K140428 | 000 |
| 05704916000134 | K140428 | 000 |
| 05704916000011 | K140428 | 000 |