The following data is part of a premarket notification filed by B-k Medical A/s with the FDA for Ultrasound Scanner Pro Focus, Model 2202.
| Device ID | K043524 |
| 510k Number | K043524 |
| Device Name: | ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | B-K MEDICAL A/S MILEPARKEN 34 Herlev, DK Dk-2730 |
| Contact | Villy Braender |
| Correspondent | Villy Braender B-K MEDICAL A/S 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-20 |
| Decision Date | 2005-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05704916000677 | K043524 | 000 |
| 05704916000523 | K043524 | 000 |
| 05704916000516 | K043524 | 000 |
| 05704916000509 | K043524 | 000 |
| 05704916000493 | K043524 | 000 |
| 05704916000486 | K043524 | 000 |
| 05704916000479 | K043524 | 000 |
| 05704916000462 | K043524 | 000 |
| 05704916000455 | K043524 | 000 |
| 05704916000448 | K043524 | 000 |
| 05704916000530 | K043524 | 000 |
| 05704916000547 | K043524 | 000 |
| 05704916000554 | K043524 | 000 |
| 05704916000660 | K043524 | 000 |
| 05704916000646 | K043524 | 000 |
| 05704916000639 | K043524 | 000 |
| 05704916000622 | K043524 | 000 |
| 05704916000615 | K043524 | 000 |
| 05704916000592 | K043524 | 000 |
| 05704916000585 | K043524 | 000 |
| 05704916000578 | K043524 | 000 |
| 05704916000561 | K043524 | 000 |
| 05704916000431 | K043524 | 000 |