The following data is part of a premarket notification filed by B-k Medical Aps with the FDA for Ultrasound Scanner Flex Focus, Model 1202.
| Device ID | K081154 |
| 510k Number | K081154 |
| Device Name: | ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | B-K MEDICAL APS MILEPARKEN 34 Herlev, DK Dk-2730 |
| Contact | Jens Rasmussen |
| Correspondent | Jens Rasmussen 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-23 |
| Decision Date | 2008-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05704916001087 | K081154 | 000 |
| 05704916001070 | K081154 | 000 |
| 05704916001063 | K081154 | 000 |
| 05704916001056 | K081154 | 000 |
| 05704916001049 | K081154 | 000 |
| 05704916000608 | K081154 | 000 |