The following data is part of a premarket notification filed by Bk Medical Aps with the FDA for Ultrasound System 1300.
| Device ID | K173569 |
| 510k Number | K173569 |
| Device Name: | Ultrasound System 1300 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BK Medical ApS Mileparken 34 Herlev, DK 2730 |
| Contact | Karen Provencher |
| Correspondent | Karen Provencher BK Medical ApS Mileparken 34 Herlev, DK 2730 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-20 |
| Decision Date | 2018-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05704916001285 | K173569 | 000 |
| 05704916001414 | K173569 | 000 |
| 05704916001407 | K173569 | 000 |
| 05704916001698 | K173569 | 000 |
| 05704916001667 | K173569 | 000 |
| 05704916001544 | K173569 | 000 |
| 05704916001537 | K173569 | 000 |
| 05704916001360 | K173569 | 000 |
| 05704916001353 | K173569 | 000 |
| 05704916001346 | K173569 | 000 |
| 05704916001421 | K173569 | 000 |
| 05704916001438 | K173569 | 000 |
| 05704916001445 | K173569 | 000 |
| 05704916000370 | K173569 | 000 |
| 05704916000363 | K173569 | 000 |
| 05704916000325 | K173569 | 000 |
| 05704916001582 | K173569 | 000 |
| 05704916001575 | K173569 | 000 |
| 05704916001568 | K173569 | 000 |
| 05704916001551 | K173569 | 000 |
| 05704916001520 | K173569 | 000 |
| 05704916001513 | K173569 | 000 |
| 05704916000974 | K173569 | 000 |