The following data is part of a premarket notification filed by Biim Ultrasound As with the FDA for Biim Diagnostic Ultrasound System.
| Device ID | K173138 |
| 510k Number | K173138 |
| Device Name: | Biim Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Biim Ultrasound AS Frydenlundsgt 9 Narvik, NO 8516 |
| Contact | Rune Nystad |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2017-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07090045490310 | K173138 | 000 |
| 07090045490068 | K173138 | 000 |
| 07090045490051 | K173138 | 000 |
| 07090045490037 | K173138 | 000 |
| 07090045490020 | K173138 | 000 |
| 07090045490013 | K173138 | 000 |
| 07090045490006 | K173138 | 000 |
| 07090045490358 | K173138 | 000 |
| 07090045490334 | K173138 | 000 |
| 07090045490327 | K173138 | 000 |
| 07090045490099 | K173138 | 000 |
| 07090045490136 | K173138 | 000 |
| 07090045490303 | K173138 | 000 |
| 07090045490242 | K173138 | 000 |
| 07090045490266 | K173138 | 000 |
| 07090045490235 | K173138 | 000 |
| 07090045490228 | K173138 | 000 |
| 07090045490198 | K173138 | 000 |
| 07090045490181 | K173138 | 000 |
| 07090045490150 | K173138 | 000 |
| 07090045490143 | K173138 | 000 |
| 07090045490365 | K173138 | 000 |